(137 days)
Over-The-Counter Use: TENS[ (Program 19, Program 15 (Frequency < 5Hz or > 15Hz)]: XFT-2000 is used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities. XFT-2000 is also intended for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. NMES[ (Program 1014, Program 15(5Hz≤Frequency≤50Hz)]: XFT-2000 is used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. XFT-2000 is also intended to temporarily increase local blood circulation in health muscles of lower extremities. Prescription Use: XFT-2000 is intended for the following use: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion - Adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
Nerve and Muscle Stimulator (model: XFT-2000) is based on the principles of neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS).The instrument has two independent channels, easy to operate and use. It can relieve muscle spasm, prevent or delay disuse muscle atrophy, promote local blood circulation, promote muscle function recovery, stimulate calf muscle after surgery to prevent venous thrombosis and maintain or increase the range of activity, and assist in the management of post-operative and post-traumatic acute pain problems. Nerve and Muscle Stimulator (model: XFT-2000) is powered by DC adapter or 3 dry AAA batteries, and used together with self-adhesive Electrode. The device is for both prescription and over the counter. It is neither for lifesupporting nor for implanting. It does not contain any drug or biological product and it does not need to be sterilized.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Nerve and Muscle Stimulator (model: XFT-2000), extracted from the FDA 510(k) summary (K193275).
It's important to note that this document is a 510(k) summary for substantial equivalence, not a detailed clinical study report. Therefore, some information, especially regarding specific clinical study methodologies, may be absent or generalized.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to predicate devices (K082011 and K162517) through compliance with recognized consensus standards and by showing that any differences do not affect safety or effectiveness. The reported device performance is presented as compliance with these standards and a detailed comparison of technical parameters to the predicate devices.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from standards and predicate comparison) | Reported Device Performance (XFT-2000) |
|---|---|---|
| Safety and Effectiveness | Substantial equivalence to predicate devices (K082011, K162517) | Stated as "substantially equivalent" |
| Performance (General) | Compliance with IEC 60601-2-10 (Medical Electrical Equipment - Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators) | Compliant |
| Biocompatibility | All patient-contacting materials comply with ISO 10993-1/-5/-10 | Compliant |
| Electrical Safety | Compliance with IEC 60601-1 (General Requirements For Basic Safety And Essential Performance) | Compliant |
| EMC (Electromagnetic Compatibility) | Compliance with IEC 60601-1-2 (Electromagnetic Disturbances - Requirements And Tests) | Compliant |
| Home Healthcare Environment | Compliance with IEC 60601-1-11 (Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment) | Compliant |
| Connecting Safety | Compliance with 21 CFR 898 | Compliant |
| Technical Parameters | Technical parameters (Output Voltage, Current, Pulse Duration, Frequency, etc.) comparable to or within the established safe and effective ranges of predicate devices, with differences not affecting safety or efficacy. | Detailed comparison provided in Tables 03-1 to 03-15 and Notes 02-05, indicating that differences do not affect safety and effectiveness. |
| Output Modes/Programs | Number and functionality of output modes demonstrate substantial equivalence in terms of intended use. | 15 modes, compared to 9 (K082011) and 8 (K162517). Differences do not affect safety/effectiveness (Note 02). |
| Power Source | DC adapter or 3 dry AAA batteries, meeting relevant safety standards. | DC4.5V, 3 × AAA batteries; DC Adapter. DC adaptor meets IEC 60601-1 standard (Note 01). |
| Waveform | Pulsed, Symmetrical balanced biphasic wave (rectangular) comparable to predicate devices. | Pulsed, Symmetrical balanced biphasic wave (rectangular) – Same as K082011, comparable to K162517. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document explicitly states "N/A" for clinical tests (Section 5.8). The evaluation primarily relies on non-clinical tests demonstrating compliance with recognized standards and a comparison of technical specifications to legally marketed predicate devices. Therefore, there isn't a "test set" here in the sense of patient data used for performance claims.
- Data Provenance: Not applicable in the context of a clinical test set. The data provenance relates to the technical specifications of the device itself and the predicate devices. This information is derived from the device's design and engineering specifications, and the publicly available information for the predicate devices (K082011, K162517). The manufacturer is Shenzhen XFT Medical Limited in China.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. As noted above, no clinical "test set" with ground truth established by experts was conducted for this 510(k) submission. The performance comparison is based on engineering specifications and adherence to international standards.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication was conducted.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device (Nerve and Muscle Stimulator) is a physical therapy device and not an AI-powered diagnostic or interpretive tool that would involve "human readers" or AI assistance in the way typically seen in imaging or other diagnostic fields. No MRMC study was mentioned or performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system. Its performance is inherent to its electrical and mechanical design, validated through compliance with engineering standards.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is established through compliance with international consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, ISO 10993-5, ISO 10993-10) and through demonstrating that its technical specifications and intended uses are substantially equivalent to legally marketed predicate devices whose safety and effectiveness have already been established. The comparison relies on documented device parameters and publicly available information for the predicate devices.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" as it is not an algorithm or AI system that learns from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 11, 2020
Shenzhen XFT Medical Limited % Field Fu Senior Consultant Shenzhen Joyantech Consulting Co., Ltd. Room 1122#, International Mayors Communication Centre NO. 55 Shizhou middl Shenzhen, Guangdong, China Re: K193275 Trade/Device Name: Nerve and Muscle Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ Dated: January 6, 2020 Received: January 13, 2020
Dear Field Fu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Vivek Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193275
Device Name Nerve and Muscle Stimulator
Indications for Use (Describe) Over-The-Counter Use: TENS[ (Program 1~9, Program 15 (Frequency < 5Hz or > 15Hz)]: XFT-2000 is used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.
XFT-2000 is also intended for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
NMES[ (Program 10~14, Program 15(5Hz≤Frequency≤50Hz)]:
XFT-2000 is used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
XFT-2000 is also intended to temporarily increase local blood circulation in health muscles of lower extremities.
Prescription Use:
XFT-2000 is intended for the following use:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
- Adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
× Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
This summary of 510(K) safety and effectiveness information is submitted As Required by requirements of SMDA and 21 CFR §807.92.
5.1 Administrative Information
| Date of Summaryprepared | Oct. 23, 2019 |
|---|---|
| Manufacturerinformation | Company title: Shenzhen XFT Medical Limited. |
| Company address:Room 203, Building 1, Biomedicine InnovationsIndustrial Park, #14 Jinhui Road, Pingshan NewDistrict, Shenzhen, China.Contact person: Cindy PengPhone: +86 755 29888818 | |
| Fax: +86-0755-28312625 | |
| E-mail: xftrs2@xft.cn | |
| SubmissionCorrespondent | Shenzhen Joyantech Consulting Co., Ltd.Address: 1713A, 17th Floor, Block A,Zhongguan Times Square, Liuxian Avenue, Xili |
| Town, Nanshan District, Shenzhen, GuangdongProvince, China. | |
| Contact person: Mr. Field Fu | |
| Image: logo | E-Mail: field@cefda.com; |
| Establishmentregistration number |
5.2 Device Information
| Type of 510(k)submission: | Traditional |
|---|---|
| Trade Name: | Nerve and Muscle Stimulator |
| Model: | XFT-2000 |
| Stimulator, Muscle, Powered; | |
| Classificationname: | Stimulator, Nerve, |
| Transcutaneous, For Pain Relief. |
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| Review Panel: | Physical Medicine; Neurology. |
|---|---|
| Product Code: | IPF; GZJ. |
| Device Class: | II |
| Regulation Number: | 890.5850; 882.5890. |
5.3 Predicate Device Information
| Sponsor: | Rio-Medical Research Ltd. |
|---|---|
| Device: | MediStim XP, Type 281; |
| 510(K) Number: | K082011 |
| Sponsor: | JKH Health Co., Ltd. |
| Device: | Electronic Pulse Stimulator |
| 510(K) Number: | K162517 |
5.4 Device Description
Nerve and Muscle Stimulator (model: XFT-2000) is based on the principles of neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS).The instrument has two independent channels, easy to operate and use. It can relieve muscle spasm, prevent or delay disuse muscle atrophy, promote local blood circulation, promote muscle function recovery, stimulate calf muscle after surgery to prevent venous thrombosis and maintain or increase the range of activity, and assist in the management of post-operative and post-traumatic acute pain problems.
Nerve and Muscle Stimulator (model: XFT-2000) is powered by DC adapter or 3 dry AAA batteries, and used together with self-adhesive Electrode.
The device is for both prescription and over the counter. It is neither for lifesupporting nor for implanting. It does not contain any drug or biological product and it does not need to be sterilized.
5.5 Intended Use/ Indications for Use
Over-The-Counter Use:
TENS[ (Program 1~9, Program 15 (Frequency<5Hz or >15Hz)]: XFT-2000 is used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.
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XFT-2000 is also intended for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
NMES[ (Program 10~14, Program 15(5Hz≤Frequency≤50Hz)]: XFT-2000 is used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
XFT-2000 is also intended to temporarily increase local blood circulation in health muscles of lower extremities.
Prescription Use:
XFT-2000 is intended for the following use:
-
Relaxation of muscle spasms
-
Prevention or retardation of disuse atrophy
-
Increasing local blood circulation
-
Muscle re-education
-
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
-
Maintaining or increasing range of motion
-
Adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
5.6 Technological characteristics of the subject device compared to the predicate device
See next pages.
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| Elements ofComparison | Subject Device | Predicate Device | Predicate Device | Remarks | |
|---|---|---|---|---|---|
| 510(k) Number | K193275 | K082011 | K162517 | ||
| Manufacturer | Shenzhen XFTMedical Limited | Rio-MedicalResearch Ltd | JKH USA, LLC | ||
| Devicetype/model | XFT-2000 | Medistim XP Type 281; | PL-029K12; | / | |
| Intended use/Indicationforuse | NeuromuscularElectrical Stimulation(NMES) for relaxationof muscle spasms,prevention orretardation of disuseatrophy, increasinglocal blood circulation,muscle re-education,immediate post-surgical stimulation ofcalf muscles to preventvenous thrombosisand maintaining orincreasing range ofmotion.TranscutaneousElectrical NerveStimulation (TENS) foran adjunctivetreatment in themanagement of post-surgical and post-traumatic acute painproblems. | Medistim XP deliversstimulation based on theprinciples ofNeuromuscular ElectricalNerveStimulation(NMIES) and alsoTranscutaneousElectrical NerveStimulation (TENS).Theindications for useare as follows:Neuromuscular ElectricalStimulation for relaxationofmuscle spasms,prevention or retardationof disuse atrophy,increasing local bloodcirculation,muscle re-education, immediatepost-surgical stimulationof calf muscles toprevent venousthrombosis andmaintaining or increasingrange of motion.TranscutaneousElectricalNerveStimulation(TENS) for an adjunctivetreatment in themanagement of post-surgical and post-traumatic acute painproblems. | TENS (Modes 1, 2, 4,5, 6, 8):To be used fortemporary relief of painassociated with soreand aching muscles inthe shoulder, waist,back, arm, and leg,due to strain fromexercise or normalhousehold and workactivities.It is also intended forsymptomatic relief andmanagement ofchronic, intractablepain and relief of painassociated witharthritis.PMS (also called EMS,Modes 1, 3, 7):To stimulate healthymuscles in order toimprove and facilitatemuscle performance.To be used for theimprovement of muscletone and firmness, andfor strengtheningmuscles in the arms,abdomen, legs, andbuttocks. Not intendedfor use in any therapyor for the treatment of | SE | |
| Elements ofComparison | Subject Device | Predicate Device | Predicate Device | Remarks | |
| any medical conditionsor diseases.t is also intended totemporarily increaselocal blood circulationin the healthy musclesof lower extremities. | |||||
| PrescriptionorOTC | Prescription and OTC | Prescription | OTC | SE | |
| Electrode | 5cm round;K132588 | 5×5cm;7cm round;5cm×9cm etc.K970426,K874469,K965194 | unknown | SE | |
| Waveform | Pulsed,Symmetricalbalanced biphasicwave (rectangular) | Pulsed, SymmetricalBiphasic, Rectangularwith interphase interval | Biphasic, Rectangular | SE | |
| Performance | Compliance with IEC60601-2-10 | Compliance with IEC60601-2-10 | Compliance with IEC60601-2-10 | Same | |
| Biocompatibility | All the patientcontacting materialsare compliance withISO 10993-1/-5/-10 | All the patient contactingmaterials arecompliance with ISO10993-1/-5/-10 | All the patientcontacting materialsare compliance withISO 10993-1/-5/-10 | Same | |
| Electrical Safety | Compliance with IEC60601-1 | Compliance with IEC60601-1 | Compliance with IEC60601-1 | Same | |
| EMC | Compliance with IEC60601-1-2 | Compliance with IEC60601-1-2 | Compliance with IEC60601-1-2 | Same | |
| ConnectingSafety | 21CFR 898 | 21CFR 898 | 21CFR 898 | Same | |
| Parameter | Subject Device | Predicate Device | Predicate Device | Remarks | |
| 510(k) Number | K193275 | K082011 | K162517 | / | |
| Device Name andModel | Nerve and MuscleStimulator, XFT-2000 | MediStimi XP, Type281 | JKH Stimulator:PL-029K12, | / | |
| Manufacturer | Shenzhen XFTMedical Limited | Rio-MedicalResearch Ltd | JKH USA, LLC | / | |
| Power Source(s) | DC4.5V, 3 × AAAbatteries;DC Adapter. | 9V Battery (type6LR61) | Rechargeable ornon-rechargeablebattery | Note 01 | |
| ---Method of Line CurrentIsolation | Battery Supply, orDC Adapter | Battery Supply | Battery Supply | Note 01 | |
| ---Patient Leakage Current:Normal Condition (µA) | N/A | N/A | N/A | / | |
| ---Patient Leakage Current:Single Fault Condition (µA) | N/A | N/A | N/A | / | |
| Number of OutputModes(programs) | 15 | 9 | 8 | Note 02 | |
| Number of Output Channels: | 2 | 2 | 1 | SE | |
| ---Synchronous or Alternating? | Both | Synchronous(Multiplexed) | N/A | SE | |
| ---Method of Channel Isolation | Transistor | Transistor | N/A | SE | |
| Regulated Current orRegulated Voltage? | Regulated Current | Regulated Current | Regulated Voltage | SE | |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | SE | |
| Automatic OverloadTrip? | Yes | Yes | No | SE | |
| Automatic No-Load Trip? | Yes | Yes | Yes | Same | |
| Automatic Shut Off? | Yes | Yes | Yes | Same | |
| Patient Override Control? | Yes, Pause button. | Yes, Pause button. | Yes | Same | |
| IndicatorDisplay: | On/Off Status? | yes | yes | Yes | Same |
| Low Battery? | yes | yes | Yes | Same | |
| Voltage/CurrentLevel? | Yes | yes | Yes | Same | |
| Timer Range (minutes) | 60mins | 30mins--open | 10-540mins; | SE | |
| Compliance with VoluntaryStandards? | yes | yes | Yes | Same | |
| Compliance with 21 CFR898? | Yes | yes | Yes | Same | |
| Weight | 96g | 93g (without battery) | 25g | SE | |
| Parameter | Subject Device | Predicate Device | Predicate Device | Remarks | |
| 140g(with battery) | |||||
| Dimensions (mm) [W x H x D] | 114×66×20 | 105 x 71 x 31 | 69.5x36.8x14 | SE | |
| Housing Materials andConstruction | Silicone & ABS | not publicly available | Silicone & ABS | SE | |
| Parameter | Subject DeviceK193275 | Predicate DeviceK082011:Type 281 | Predicate DeviceK162517:PL-029K12 | ||
| Mode or Program Name | P1 | P4 | P7 | ||
| Maximum Output Voltage (volts)(+/-20%) | 30.0V@500Ω90.6V@ 2 kΩ123V@10 kΩ | 37.5V@500Ωnot publicly availablenot publicly available | 40.8V@500Ω86.4V@ 2 kΩ129V@10 kΩ | ||
| Maximum Output Current (specify units) (+/- 20%) | 60.0mA@500Ω45.3mA@ 2 kΩ12.3mA@10 kΩ | 75.0mA@500Ωnot publicly availablenot publicly available | 81.6mA@500Ω43.2mA@ 2 kΩ12.9mA@10 kΩ | ||
| Pulse Duration/width† (µsec) | 250 | 300 | 100 (Note 03) | ||
| Frequency† (Hz) [or Rate† (pps)] | 35 | 35 | 19.8 | ||
| For interferential modes only:-Beat Frequency (Hz) | N/A | N/A | N/A | ||
| For multiphasic waveforms only: | Symmetrical phases?Phase Duration† (include units), (state range, if applicable), (both phases, if asymmetrical) | N/A | N/A | N/A | |
| Net Charge (microcoulombs (µC) per pulse) (If zero, state method of achieving zero net charge.) | 15@500Ω | 22.5@500Ω | 16.3@500Ω | ||
| Maximum Phase Charge, (µC) | 15@500Ω | 22.5@500Ω | 16.3@500Ω | ||
| Maximum Current Density,††(mA/cm2.) | 0.46@500Ω | 0.43@500Ω | 3.26@500Ω | ||
| Maximum Power Density,†† (W/cm2), (using smallest electrode conductive surface area) | 0.0018@500Ω | 0.0024@500Ω | 0.00053@500Ω | ||
| Burst Mode (i.e., pulse trains): | (a) Pulses per burst 315 (Note 04)(b) Bursts per second 0.11(c) Burst duration (seconds) 9(d) Duty Cycle: Line (b) x Line (c) 1 | (a) Pulses per burst 245(b) Bursts per second 0.14(c) Burst duration (seconds) 7(d) Duty Cycle: Line (b) x Line (c) 1 | NA | ||
| ON Time (seconds) | 9 | 7 | 3.4~20 | ||
| OFF Time (seconds) | 5 | 5 | 1~2.5 | ||
| Additional Features (specify, if applicable) | N/A | N/A | N/A | ||
| Table 03-2: | |||||
| Parameter | Subject DeviceK193275 | Predicate DeviceK082011:Type 281 | Predicate DeviceK162517:PL-029K12 | ||
| Mode or Program Name | P2 | P4 | P7 | ||
| Maximum Output Voltage (volts)(+/-20%) | 30.0V@500Ω90.6V@ 2 kΩ125V@10 kΩ | 37.5V@500Ωnot publicly availablenot publicly available | 40.8V@500Ω86.4V@ 2 kΩ129V@10 kΩ | ||
| Maximum Output Current (specifyunits) (+/- 20%) | 60.0mA@500Ω45.3mA@ 2 kΩ12.5mA@10 kΩ | 75.0mA@500Ωnot publicly availablenot publicly available | 81.6mA@500Ω43.2mA@ 2 kΩ12.9mA@10 kΩ | ||
| Pulse Duration/width† (µsec) | 250 | 300 | 100 (Note 03) | ||
| Frequency† (Hz) [or Rate† (pps)] | 35 | 35 | 19.8 | ||
| For interferential modes only:-Beat Frequency (Hz) | N/A | N/A | N/A | ||
| Formultiphasicwaveformsonly: | Symmetrical phases?PhaseDuration† (includeunits),(state range, ifapplicable),(both phases, ifasymmetrical) | N/A | N/A | N/A | |
| Net Charge (microcoulombs (μC)per pulse) (If zero, state method ofachieving zero net charge.) | 15@500Ω | 22.5@500Ω | 16.3@500Ω | ||
| Maximum Phase Charge, (µC) | 15@500Ω | 22.5@500Ω | 16.3@500Ω | ||
| Maximum CurrentDensity,††(mA/cm2.) | 0.46@500Ω | 0.43@500Ω | 3.26@500Ω | ||
| Maximum PowerDensity,†† (W/cm2), (using smallestelectrode conductive surface area) | 0.0018@500Ω | 0.0023@500Ω | 0.00053@500Ω | ||
| Burst Mode(i.e., pulsetrains): | (a) Pulses per burst(b) Bursts per second(c) Burst duration(seconds)(d) Duty Cycle: Line(b) x Line (c) | 490(Note 04)0.07141 | 2450.1471 | NANANANA | |
| ON Time (seconds) | 14 | 7 | 3.4~20 | ||
| OFF Time (seconds) | 10 | 5 | 1~2.5 | ||
| Additional Features (specify, ifapplicable) | N/A | N/A | N/A | ||
| Table 03-3: | |||||
| Parameter | Subject DeviceK193275 | Predicate DeviceK082011:Type 281 | Predicate DeviceK162517:PL-029K12 | ||
| Mode or Program Name | P3 | P4 | P7 | ||
| Maximum Output Voltage (volts)(+/-20%) | 30.0V@500Ω90.6V@ 2 kΩ125Vpp@10 kΩ | 37.5V@500Ωnot publicly availablenot publicly available | 40.8V@500Ω86.4V@ 2 kΩ129V@10 kΩ | ||
| Maximum Output Current (specify units) (+/- 20%) | 60.0mA@500Ω45.3mA@ 2 kΩ12.5mA@10 kΩ | 75.0mA@500Ωnot publicly availablenot publicly available | 81.6mA@500Ω43.2mA@ 2 kΩ12.9mA@10 kΩ | ||
| Pulse Duration† (µsec) | 250 | 300 | 100 (Note 03) | ||
| Frequency† (Hz) [or Rate† (pps)] | 35 | 35 | 19.8 | ||
| For interferential modes only:-Beat Frequency (Hz) | N/A | N/A | N/A | ||
| For multiphasic waveforms only: | Symmetrical phases?Phase Duration† (include units),(state range, if applicable),(both phases, if asymmetrical) | N/A | N/A | N/A | |
| Net Charge (microcoulombs (μC) per pulse) (If zero, state method of achieving zero net charge.) | 15@500Ω | 22.5@500Ω | 16.3@500Ω | ||
| Maximum Phase Charge, (µC) | 15@500Ω | 22.5@500Ω | 16.3@500Ω | ||
| Maximum Current Density,††(mA/cm2.) | 0.46@500Ω | 0.43@500Ω | 3.26@500Ω | ||
| Maximum Power Density,†† (W/cm2), (using smallest electrode conductive surface area) | 0.0018@500Ω | 0.0024@500Ω | 0.00053@500Ω | ||
| Burst Mode (i.e., pulse trains): | (a) Pulses per burst(b) Bursts per second(c) Burst duration (seconds)(d) Duty Cycle: Line (b) x Line (c) | 315(Note 04)0.1191 | 2450.1471 | NANANANA | |
| ON Time (seconds) | 9 | 7 | 3.4~20 | ||
| OFF Time (seconds) | 5 | 5 | 1~2.5 | ||
| Additional Features (specify, if applicable) | N/A | N/A | N/A | ||
| Table 03-4: | |||||
| Parameter | Subject DeviceK193275 | Predicate DeviceK082011:Type 281 | Predicate DeviceK162517:PL-029K12 | ||
| Mode or Program Name | P4 | P1 | P3 | ||
| Maximum Output Voltage (volts)(+/-20%) | 30.0V@500Ω90.6V@ 2 kΩ125V@10 kΩ | 37.5V@500Ωnot publicly availablenot publicly available | 47.6V@500Ω96.0V@ 2 kΩ132V@10 kΩ | ||
| Maximum Output Current (specifyunits) (+/- 20%) | 60.0mA@500Ω45.3mA@ 2 kΩ12.5mA@10 kΩ | 75.0mA@500Ωnot publicly availablenot publicly available | 95.2mA@500Ω48.0mA@ 2 kΩ13.2mA@10 kΩ | ||
| Pulse Duration/width† (µsec) | 250 | 300 | 100 (Note 03) | ||
| Frequency† (Hz) [or Rate† (pps)] | 60 | 50 | 12.8~54.3 | ||
| For interferential modes only:-Beat Frequency (Hz) | N/A | N/A | N/A | ||
| Formultiphasicwaveformsonly: | Symmetrical phases?PhaseDuration† (includeunits),(state range, ifapplicable),(both phases, ifasymmetrical) | N/A | N/A | N/A | |
| Net Charge (microcoulombs (µC)per pulse) (If zero, state method ofachieving zero net charge.) | 15@500Ω | 22.5@500Ω | 19.0@500Ω | ||
| Maximum Phase Charge, (µC) | 15@500Ω | 22.5@500Ω | 19.0@500Ω | ||
| Maximum CurrentDensity,††(mA/cm2.) | 0.60@500Ω | 0.52@500Ω | 2.64@500Ω | ||
| Maximum PowerDensity,†† (W/cm2), (using smallestelectrode conductive surface area) | 0.0031@500Ω | 0.0034@500Ω | 0.00032~0.00137@500Ω | ||
| Burst Mode(i.e., pulsetrains): | (a) Pulses per burst(b) Bursts per second(c) Burst duration(seconds)(d) Duty Cycle: Line(b) x Line (c) | 840(Note 04)0.07141 | 3500.1471 | NANANANA | |
| ON Time (seconds) | 14 | 7 | 3.4~20 | ||
| OFF Time (seconds) | 10 | 5 | 1~2.5 | ||
| Additional Features (specify, ifapplicable) | N/A | N/A | N/A | ||
| Table 03-5: | |||||
| Parameter | Subject DeviceK193275 | Predicate DeviceK082011:Type 281 | Predicate DeviceK162517:PL-029K12 | ||
| Mode or Program Name | P5 | P3 | P7 | ||
| Maximum Output Voltage (volts)(+/-20%) | 30.0V@500Ω | 37.5V@500Ωnot publicly available | 40.8V@500Ω | ||
| 90.6V@ 2 kΩ | 86.4V@ 2 kΩ | ||||
| 125V@10 kΩ | not publicly available | 129V@10 kΩ | |||
| Maximum Output Current (specifyunits) (+/- 20%) | 60.0mA@500Ω | 75.0mA@500Ωnot publicly available | 81.6mA@500Ω | ||
| 45.3mA@ 2 kΩ | 43.2mA@ 2 kΩ | ||||
| 12.5mA@10 kΩ | not publicly available | 12.9mA@10 kΩ | |||
| Pulse Duration† (µsec) | 300 | 300 | 100 (Note 03) | ||
| Frequency† (Hz) [or Rate† (pps)] | 35 | 35 | 19.8 | ||
| For interferential modes only:-Beat Frequency (Hz) | N/A | N/A | N/A | ||
| Formultiphasicwaveformsonly: | Symmetrical phases? N/A | N/A | N/A | ||
| PhaseDuration† (includeunits),(state range, ifapplicable),(both phases, ifasymmetrical) | N/A | N/A | N/A | ||
| Net Charge (microcoulombs (μC)per pulse) (If zero, state method ofachieving zero net charge.) | 18@500Ω | 22.5@500Ω | 16.3@500Ω | ||
| Maximum Phase Charge, (µC) | 18@500Ω | 22.5@500Ω | 16.3@500Ω | ||
| Maximum CurrentDensity,††(mA/cm2.) | 0.50@500Ω | 0.60@500Ω | 3.26@500Ω | ||
| Maximum PowerDensity,†† (W/cm2), (using smallestelectrode conductive surface area) | 0.0022@500Ω | 0.0045@500Ω | 0.00053@500Ω | ||
| Burst Mode(i.e., pulsetrains): | (a) Pulses per burst 420(Note 04) | 245 | NA | ||
| (b) Bursts per second 0.08 | 0.14 | NA | |||
| (c) Burst duration(seconds) 12 | 7 | NA | |||
| (d) Duty Cycle: Line(b) x Line (c) 1 | 1 | NA | |||
| ON Time (seconds) | 12 | 7 | 3.4~20 | ||
| OFF Time (seconds) | 8 | 5 | 1~2.5 | ||
| Additional Features (specify, ifapplicable) | N/A | N/A | N/A | ||
| Table 03-6: | |||||
| Parameter | Subject DeviceK193275 | Predicate DeviceK082011:Type 281 | Predicate DeviceK162517:PL-029K12 | ||
| Mode or Program Name | P6 | P7 | P7 | ||
| Maximum Output Voltage (volts)(+/-20%) | 30.0V@500Ω90.6V@ 2 kΩ125V@10 kΩ | 37.5V@500Ωnot publiclyavailablenot publiclyavailable | 40.8V@500Ω86.4V@ 2 kΩ129V@10 kΩ | ||
| Maximum Output Current (specifyunits) (+/- 20%) | 60.0mA@500Ω45.3mA@ 2 kΩ12.5mA@10 kΩ | 75.0mA@500Ωnot publiclyavailablenot publiclyavailable | 81.6mA@500Ω43.2mA@ 2 kΩ12.9mA@10 kΩ | ||
| Pulse Duration† (µsec) | 350 | 350 | 100 (Note 03) | ||
| Frequency† (Hz) [or Rate† (pps)] | 35 | 35 | 19.8 | ||
| For interferential modes only:-Beat Frequency (Hz) | N/A | N/A | N/A | ||
| Formultiphasicwaveformsonly: | Symmetrical phases? N/APhaseDuration† (includeunits),(state range, ifapplicable),(both phases, ifasymmetrical) | N/A | N/A | N/A | |
| Net Charge (microcoulombs (μC)per pulse) (If zero, state method ofachieving zero net charge.) | 21@500Ω | 26.25@500Ω | 16.3@500Ω | ||
| Maximum Phase Charge, (µC) | 21@500Ω | 26.25@500Ω | 16.3@500Ω | ||
| Maximum CurrentDensity,††(mA/cm2.) | 0.54@500Ω | 0.47@500Ω | 3.26@500Ω | ||
| Maximum PowerDensity,†† (W/cm2), (using smallestelectrode conductive surface area) | 0.0026@500Ω | 0.0028@500Ω | 0.00053@500Ω | ||
| Burst Mode(i.e., pulsetrains): | (a) Pulses per burst 315(Note 04)(b) Bursts per second 0.11(c) Burst duration(seconds) 9(d) Duty Cycle: Line(b) x Line (c) 1 | 2270.146.51 | NANANANA | ||
| ON Time (seconds) | 14 | 6.5 | 3.4~20 | ||
| OFF Time (seconds) | 10 | 5 | 1~2.5 | ||
| Additional Features (specify, ifapplicable) | N/A | N/A | N/A |
Table 01: SE Comprehensive Comparison Table
{8}------------------------------------------------
{9}------------------------------------------------
Table 02: SE General Specification Comparison Table
{10}------------------------------------------------
Note 01: DC adaptor meets IEC 60601-1 standard.
Note 02: Number of Output Modes(programs) do not directly affect the affect safety and effectiveness of the subject device, for instance, the number of output modes for electrical stimulator model SEM44 (K171803) is respectively 35(EMS) and 15(TENS), and the number of output modes its predicate device model MT9001/LT3060 (K130802) is respectively 1(EMS) and 1(TENS). In addition, based on "Table 03: SE Detailed Comparison Table", P1, P2 , P3 of the subject device corresponds to P4 of K082011(type 281)and P7 of K162517 (PL-029K12); P4 corresponds to corresponds to P1 of K082011(type 281)and P3 of K162517 (PL-029K12), P5~P15 of the subject device corresponds also corresponds to one mode of K082011(type 281)and one mode of K162517 (PL-029K12). Also, according to the discussion in Note 03, Note 04, the difference between the parameters of mode of the subject device and the parameters of mode the predicate devices do not affect safety and effectiveness of the subject device, therefore, the difference of output mode number do not the determination of substantial equivalence.
{11}------------------------------------------------
Table 03: SE Detailed Comparison Table
Table 03-1:
{12}------------------------------------------------
{13}------------------------------------------------
{14}------------------------------------------------
{15}------------------------------------------------
{16}------------------------------------------------
{17}------------------------------------------------
| Table 03-7: | ||||
|---|---|---|---|---|
| Parameter | Subject DeviceK193275 | Predicate DeviceK082011:Type 281 | Predicate DeviceK162517:PL-029K12 | |
| Mode or Program Name | P7 | P7 | P7 | |
| Maximum Output Voltage (volts)(+/-20%) | 30.0V@500Ω89.1V@ 2 kΩ125V@10 kΩ | 37.5V@500Ωnot publicly availablenot publicly available | 40.8V@500Ω86.4V@ 2 kΩ129V@10 kΩ | |
| Maximum Output Current (specify units) (+/- 20%) | 60.0mA@500Ω44.5mA@ 2 kΩ12.5mA@10 kΩ | 75.0mA@500Ωnot publicly availablenot publicly available | 81.6mA@500Ω43.2mA@ 2 kΩ12.9mA@10 kΩ | |
| Pulse Duration† (µsec) | 350 | 350 | 100 (Note 03) | |
| Frequency† (Hz) [or Rate† (pps)] | 35 | 35 | 19.8 | |
| For interferential modes only:-Beat Frequency (Hz) | N/A | N/A | N/A | |
| For multiphasic waveforms only: | Symmetrical phases? N/APhase Duration† (include units),(state range, if applicable),(both phases, if asymmetrical) N/A | N/A | N/A | |
| Net Charge (microcoulombs (μC) per pulse) (If zero, state method of achieving zero net charge.) | 21@500Ω | 26.25@500Ω | 16.3@500Ω | |
| Maximum Phase Charge, (µC) | 21@500Ω | 26.25@500Ω | 16.3@500Ω | |
| Maximum Current Density,††(mA/cm2.) | 0.54@500Ω | 0.47@500Ω | 3.26@500Ω | |
| Maximum Power Density,†† (W/cm2), (using smallest electrode conductive surface area) | 0.0026@500Ω | 0.0028@500Ω | 0.00053@500Ω | |
| Burst Mode (i.e., pulse trains): | (a) Pulses per burst 490(Note 04)(b) Bursts per second 0.07(c) Burst duration (seconds) 14(d) Duty Cycle: Line (b) x Line (c) 1 | 2270.156.51 | NANANANA | |
| ON Time (seconds) | 14 | 6.5 | 3.4~20 | |
| OFF Time (seconds) | 10 | 5 | 1~2.5 | |
| Additional Features (specify, if applicable) | N/A | N/A | N/A | |
| Table 03-8: | ||||
| Parameter | Subject DeviceK193275 | Predicate DeviceK082011:Type 281 | Predicate DeviceK162517:PL-029K12 | |
| Mode or Program Name | P8 | P7 | P7 | |
| Maximum Output Voltage (volts)(+/-20%) | 30.0V@500Ω89.1V@ 2 kΩ125V@10 kΩ | 37.5V@500Ωnot publiclyavailablenot publiclyavailable | 40.8V@500Ω86.4V@ 2 kΩ129V@10 kΩ | |
| Maximum Output Current (specifyunits) (+/- 20%) | 60.0mA@500Ω44.5mA@ 2 kΩ12.5mA@10 kΩ | 75.0mA@500Ωnot publiclyavailablenot publiclyavailable | 81.6mA@500Ω43.2mA@ 2 kΩ12.9mA@10 kΩ | |
| Pulse Duration† (µsec) | 350 | 350 | 100 (Note 03) | |
| Frequency† (Hz) [or Rate† (pps)] | 35 | 35 | 19.8 | |
| For interferential modes only:-Beat Frequency (Hz) | N/A | N/A | N/A | |
| Formultiphasicwaveformsonly: | Symmetrical phases? | N/A | N/A | N/A |
| PhaseDuration† (includeunits),(state range, ifapplicable),(both phases, ifasymmetrical) | N/A | N/A | N/A | |
| Net Charge (microcoulombs (μC)per pulse) (If zero, state method ofachieving zero net charge.) | 21@500Ω | 26.25@500Ω | 16.3@500Ω | |
| Maximum Phase Charge, (µC) | 21@500Ω | 26.25@500Ω | 16.3@500Ω | |
| Maximum CurrentDensity,††(mA/cm2.) | 0.54@500Ω | 0.47@500Ω | 3.26@500Ω | |
| Maximum PowerDensity,†† (W/cm2), (using smallestelectrode conductive surface area) | 0.0026@500Ω | 0.0028@500Ω | 0.00053@500Ω | |
| Burst Mode(i.e., pulsetrains): | (a) Pulses per burst | 315(Note 04) | 227 | NA |
| (b) Bursts per second | 0.11 | 0.15 | NA | |
| (c) Burst duration(seconds) | 9 | 6.5 | NA | |
| (d) Duty Cycle: Line(b) x Line (c) | 1 | 1 | NA | |
| ON Time (seconds) | 9 | 6.5 | 3.4~20 | |
| OFF Time (seconds) | 9 | 5 | 1~2.5 | |
| Additional Features (specify, ifapplicable) | N/A | N/A | N/A | |
| Table 03-9: | Subject DeviceK193275 | Predicate DeviceK082011:Type 281 | Predicate DeviceK162517:PL-029K12 | |
| Parameter | ||||
| Mode or Program Name | P9 | P7 | P3 | |
| Maximum Output Voltage (volts)(+/-20%) | 30.0V@500Ω | 37.5V@500Ω | 47.6V@500Ω | |
| 90.6V@ 2 kΩ | not publiclyavailable | 96.0V@ 2 kΩ | ||
| 125V@10 kΩ | not publiclyavailable | 132V@10 kΩ | ||
| Maximum Output Current (specifyunits) (+/- 20%) | 60.0mA@500Ω | 75.0mA@500Ω | 95.2mA@500Ω | |
| 45.3mA@ 2 kΩ | not publiclyavailable | 48.0mA@ 2 kΩ | ||
| 12.5mA@10 kΩ | not publiclyavailable | 13.2mA@10 kΩ | ||
| Pulse Duration† (µsec) | 350 | 350 | 100 (Note 03) | |
| Frequency† (Hz) [or Rate† (pps)] | 60 | 35 | 12.8~54.3 | |
| For interferential modes only:-Beat Frequency (Hz) | N/A | N/A | N/A | |
| Formultiphasicwaveformsonly: | Symmetrical phases?Phase Duration† (includeunits),(state range, ifapplicable),(both phases, ifasymmetrical) | N/A | N/A | N/A |
| N/A | N/A | N/A | ||
| Net Charge (microcoulombs (µC)per pulse) (If zero, state method ofachieving zero net charge.) | 21@500Ω | 26.25@500Ω | 19.0@500Ω | |
| Maximum Phase Charge, (µC) | 21@500Ω | 26.25@500Ω | 19.0@500Ω | |
| Maximum CurrentDensity,‡‡(mA/cm2.) | 0.71@500Ω | 0.47@500Ω | 2.64@500Ω | |
| Maximum PowerDensity,‡‡ (W/cm2), (using smallestelectrode conductive surface area) | 0.0044@500Ω | 0.0028@500Ω | 0.00032~0.00137@500Ω | |
| Burst Mode(i.e., pulsetrains): | (a) Pulses per burst(b) Bursts per second(c) Burst duration(seconds)(d) Duty Cycle: Line(b) x Line (c) | 840(Note 04)0.07141 | 2270.156.51 | NANANANA |
| ON Time (seconds) | 14 | 6.5 | 3.4~20 | |
| OFF Time (seconds) | 10 | 5 | 1~2.5 | |
| Additional Features (specify, ifapplicable) | N/A | N/A | N/A | |
| Table 03-10: | ||||
| Parameter | Subject DeviceK193275 | Predicate DeviceK082011:Type 281 | Predicate DeviceK162517:PL-029K12 | |
| Mode or Program Name | P10 | P8 | P4 | |
| Maximum Output Voltage (volts)(+/-20%) | 30.0V@500Ω89.1V@ 2 kΩ125V@10 kΩ | 37.5V@500Ωnot publiclyavailablenot publiclyavailable | 57.6V@500Ω93.6V@ 2 kΩ108V@10 kΩ | |
| Maximum Output Current (specifyunits) (+/- 20%) | 60.0mA@500Ω44.5mA@ 2 kΩ12.5mA@10 kΩ | 75.0mA@500Ωnot publiclyavailablenot publiclyavailable | 115.2mA@500Ω46.8mA@ 2 kΩ10.8mA@10 kΩ | |
| Pulse Duration† (µsec) | 200 | 80 | 100 (Note 03) | |
| Frequency† (Hz) [or Rate† (pps)] | 5 | 8 | 1.19 | |
| For interferential modes only:-Beat Frequency (Hz) | N/A | N/A | N/A | |
| Formultiphasicwaveformsonly: | Symmetrical phases? N/APhaseDuration† (includeunits),(state range, ifapplicable),(both phases, ifasymmetrical) N/A | N/A | N/A | |
| Net Charge (microcoulombs (μC)per pulse) (If zero, state method ofachieving zero net charge.) | 12@500Ω | 6@500Ω | 23.0@500Ω | |
| Maximum Phase Charge, (µC) | 12@500Ω | 6@500Ω | 23.0@500Ω | |
| Maximum CurrentDensity,††(mA/cm2.) | 0.16@500Ω | 0.11@500Ω | 3.20@500Ω | |
| Maximum PowerDensity,†† (W/cm2), (using smallestelectrode conductive surface area) | 0.0002@500Ω | 0.00014@500Ω | 0.00004@500Ω | |
| Burst Mode(i.e., pulsetrains): | (a) Pulses per burst 15(Note 04)(b) Bursts per second 0.33(c) Burst duration(seconds) 3(d) Duty Cycle: Line(b) x Line (c) 1 | 520.156.51 | NANANANA | |
| ON Time (seconds) | 3 | 6.5 | 3.4~20 | |
| OFF Time (seconds) | 2 | 5 | 1~2.5 | |
| Additional Features (specify, ifapplicable) | N/A | N/A | N/A | |
| Table 03-11: | ||||
| Parameter | Subject DeviceK193275 | Predicate DeviceK082011:Type 281 | Predicate DeviceK162517:PL-029K12 | |
| Mode or Program Name | P11 | P9 | P4 | |
| Maximum Output Voltage (volts)(+/-20%) | 29.7V@500Ω89.1V@ 2 kΩ125V@10 kΩ | 37.5V@500Ωnot publiclyavailablenot publiclyavailable | 57.6V@500Ω93.6V@ 2 kΩ108V@10 kΩ | |
| Maximum Output Current (specifyunits) (+/- 20%) | 59.4mA@500Ω44.5mA@ 2 kΩ12.5mA@10 kΩ | 75.0mA@500Ωnot publiclyavailablenot publiclyavailable | 115.2mA@500Ω46.8mA@ 2 kΩ10.8mA@10 kΩ | |
| Pulse Duration† (µsec) | 200 | 150 | 100 (Note 03) | |
| Frequency† (Hz) [or Rate† (pps)] | 4 | 4~99 | 1.19 | |
| For interferential modes only:-Beat Frequency (Hz) | N/A | N/A | N/A | |
| Formultiphasicwaveformsonly: | Symmetrical phases? N/APhaseDuration† (includeunits),(state range, ifapplicable),(both phases, ifasymmetrical) N/A | N/A | N/A | |
| Net Charge (microcoulombs (μC)per pulse) (If zero, state method ofachieving zero net charge.) | 11.9@500Ω | 11.25@500Ω | 23.0@500Ω | |
| Maximum Phase Charge, (μC) | 11.9@500Ω | 11.25@500Ω | 23.0@500Ω | |
| Maximum CurrentDensity,††(mA/cm2.) | 0.14@500Ω | 0.52@500Ω | 3.20@500Ω | |
| Maximum PowerDensity,†† (W/cm2), (using smallestelectrode conductive surface area) | 0.00016@500Ω | 0.0033@500Ω | 0.00004@500Ω | |
| Burst Mode(i.e., pulsetrains): | (a) Pulses per burst N/A(b) Bursts per second IN/A(c) Burst duration(seconds) N/A(d) Duty Cycle: Line(b) x Line (c) N/A | N/A | NA | |
| ON Time (seconds) | Continuous | Continuous | 3.4~20 | |
| OFF Time (seconds) | N/A | N/A | 1~2.5 | |
| Additional Features (specify, ifapplicable) | N/A | N/A | N/A | |
| Table 03-12: | ||||
| Parameter | Subject DeviceK193275 | Predicate DeviceK082011:Type 281 | Predicate DeviceK162517:PL-029K12 | |
| Mode or Program Name | P12 | P9 | P5 | |
| Maximum Output Voltage (volts)(+/-20%) | 29.7V@500Ω89.1V@ 2 kΩ125V@10 kΩ | 37.5V@500Ωnot publiclyavailablenot publiclyavailable | 29.6V@500Ω66.4V@ 2 kΩ126V@10 kΩ | |
| Maximum Output Current (specifyunits) (+/- 20%) | 59.4mA@500Ω44.5mA@ 2 kΩ12.5mA@10 kΩ | 75.0mA@500Ωnot publiclyavailablenot publiclyavailable | 59.2mA@500Ω33.2mA@ 2 kΩ12.6mA@10 kΩ | |
| Pulse Duration⁺ (µsec) | 175 | 150 | 100 (Note 03) | |
| Frequency⁺ (Hz) [or Rate⁺ (pps)] | 125 | 4~99 | 104.1 | |
| For interferential modes only:-Beat Frequency (Hz) | N/A | N/A | N/A | |
| Formultiphasicwaveformsonly: | Symmetrical phases? N/APhaseDuration⁺ (includeunits),(state range, ifapplicable),(both phases, ifasymmetrical) N/A | N/A | N/A | |
| Net Charge (microcoulombs (µC)per pulse) (If zero, state method ofachieving zero net charge.) | 10.4@500Ω | 11.25@500Ω | 11.8@500Ω | |
| Maximum Phase Charge, (µC) | 10.4@500Ω | 11.25@500Ω | 11.8@500Ω | |
| Maximum CurrentDensity, ⁺⁺(mA/cm².) | 0.72@500Ω | 0.52@500Ω | 1.64@500Ω | |
| Maximum PowerDensity,⁺⁺ (W/cm²), (using smallestelectrode conductive surface area) | 0.0045@500Ω | 0.0033@500Ω | 0.00101@500Ω | |
| Burst Mode(i.e., pulsetrains): | (a) Pulses per burst N/A(b) Bursts per second N/A(c) Burst duration(seconds) N/A(d) Duty Cycle: Line(b) x Line (c) N/A | N/A | NA | |
| ON Time (seconds) | Continuous | Continuous | 3.4~20 | |
| OFF Time (seconds) | N/A | N/A | 1~2.5 | |
| Additional Features (specify, ifapplicable) | N/A | N/A | N/A | |
| Table 03-13: | Parameter | Subject DeviceK193275 | Predicate DeviceK082011:Type 281 | Predicate DeviceK162517:PL-029K12 |
| Mode or Program Name | P13 | P6 | P6 | |
| Maximum Output Voltage (volts)(+/-20%) | 29.4V@500Ω89.1V@ 2 kΩ123V@10 kΩ | 37.5V@500Ωnot publiclyavailablenot publiclyavailable | 29.6V@500Ω66.4V@ 2 kΩ126V@10 kΩ | |
| Maximum Output Current (specifyunits) (+/- 20%) | 58.8mA@500Ω44.5mA@ 2 kΩ12.3mA@10 kΩ | 75.0mA@500Ωnot publiclyavailablenot publiclyavailable | 59.2mA@500Ω33.2mA@ 2 kΩ12.6mA@10 kΩ | |
| Pulse Duration+ (µsec) | 150250 | 300 | 100 (Note 03) | |
| Frequency+ (Hz) [or Rate+ (pps)] | 1254 | 5010 | 104.1 | |
| For interferential modes only:-Beat Frequency (Hz) | N/A | N/A | N/A | |
| Formultiphasicwaveformsonly: | Symmetrical phases?PhaseDuration+ (includeunits),(state range, ifapplicable),(both phases, ifasymmetrical) | N/A | N/A | N/A |
| Net Charge (microcoulombs (µC)per pulse) (If zero, state method ofachieving zero net charge.) | 8.8@500Ω14.7@500Ω | 22.5@500Ω22.5@500Ω | 11.8@500Ω | |
| Maximum Phase Charge, (µC) | 8.8@500Ω14.7@500Ω | 22.5@500Ω22.5@500Ω | 11.8@500Ω | |
| Maximum CurrentDensity,++(mA/cm2.) | 0.66@500 Ω0.15@500 Ω | 0.52@500Ω0.23@500Ω | 1.64@500Ω | |
| Maximum PowerDensity,++ (W/cm2), (using smallestelectrode conductive surface area) | 0.0038@500 Ω0.0002@500 Ω | 0.0034@500Ω0.00068@500Ω | 0.00101@500Ω | |
| Burst Mode(i.e., pulsetrains): | (a) Pulses per burst | N/A | N/A | NA |
| (b) Bursts per second | N/A | N/A | NA | |
| (c) Burst duration(seconds) | N/A | N/A | NA | |
| (d) Duty Cycle: Line(b) x Line (c) | N/A | N/A | NA | |
| ON Time (seconds) | Continuous | Continuous | 3.4~20 | |
| OFF Time (seconds) | N/A | N/A | 1~2.5 | |
| Table 03-14: | ||||
| Parameter | Subject DeviceK193275 | Predicate DeviceK082011:Type 281 | Predicate DeviceK162517:PL-029K12 | |
| Mode or Program Name | P14 | P9 | P2 | |
| Maximum Output Voltage (volts)(+/-20%) | 29.4V@500Ω90.6@ 2 kΩ125Vpp@10 kΩ | 37.5V@500Ωnot publicly availablenot publicly available | 36.4V@500Ω80.8V@ 2 kΩ134V@10 kΩ | |
| Maximum Output Current (specifyunits) (+/- 20%) | 58.8mA@500Ω44.5mA@ 2 kΩ12.5mA@10 kΩ | 75.0mA@500Ωnot publicly availablenot publicly available | 72.8mA@500Ω40.4mA@ 2 kΩ13.4mA@10 kΩ | |
| Pulse Duration† (µsec) | 100 | 150 | 100 (Note 03) | |
| Frequency† (Hz) [or Rate† (pps)] | 50 | 4~99 | 62.5 | |
| For interferential modes only:-Beat Frequency (Hz) | N/A | N/A | N/A | |
| Formultiphasicwaveformsonly: | Symmetrical phases? | N/A | N/A | N/A |
| Phase Duration† (includeunits),(state range, ifapplicable),(both phases, ifasymmetrical) | N/A | N/A | N/A | |
| Net Charge (microcoulombs (μC)per pulse) (If zero, state method ofachieving zero net charge.) | 5.9@500Ω | 11.25@500Ω | 14.6@500Ω | |
| Maximum Phase Charge, (µC) | 5.9@500Ω | 11.25@500Ω | 14.6@500Ω | |
| Maximum CurrentDensity,††(mA/cm2.) | 0.34@500Ω | 0.52@500Ω | 2.02@500Ω | |
| Maximum PowerDensity,†† (W/cm2), (using smallestelectrode conductive surface area) | 0.001@500Ω | 0.0033@500Ω | 0.00092@500Ω | |
| Burst Mode(i.e., pulse trains): | (a) Pulses perburst | N/A | N/A | NA |
| (b) Bursts persecond | N/A | N/A | NA | |
| (c) Burst duration(seconds) | N/A | N/A | NA | |
| (d) Duty Cycle:Line (b) x Line (c) | N/A | N/A | NA | |
| ON Time (seconds) | Continuous | Continuous | 3.4~20 | |
| OFF Time (seconds) | N/A | N/A | 1~2.5 | |
| Additional Features (specify, ifapplicable) | N/A | N/A | N/A | |
| Table 03-15: | ||||
| Parameter | Subject DeviceK193275 | Predicate DeviceK082011:Type 281 | Predicate DeviceK162517:PL-029K12 | |
| Mode or Program Name | P15 | P9 | P1 (Note 05) | |
| Maximum Output Voltage (volts)(+/-20%) | 29.7V@500Ω89.1V@ 2 kΩ125Vpp@10 kΩ | 37.5V@500Ωnot publicly availablenot publicly available | / | |
| Maximum Output Current (specifyunits) (+/- 20%) | 59.4mA@500Ω44.5mA@ 2 kΩ12.5mA@10 kΩ | 75.0mA@500Ωnot publicly availablenot publicly available | / | |
| Pulse Duration† (µsec) | 100~350 | 150 | / | |
| Frequency† (Hz) [or Rate† (pps)] | 1~125 | 4~99 | / | |
| For interferential modes only:-Beat Frequency (Hz) | N/A | N/A | / | |
| Formultiphasicwaveformsonly: | Symmetrical phases? N/APhaseDuration† (includeunits),(state range, ifapplicable),(both phases, ifasymmetrical) | N/A | / | |
| Net Charge (microcoulombs (μC)per pulse) (If zero, state method ofachieving zero net charge.) | 20.8@500Ω | 11.25@500Ω | / | |
| Maximum Phase Charge, (µC) | 20.8@500Ω | 11.25@500Ω | / | |
| Maximum CurrentDensity,††(mA/cm2.) | 1.02@500Ω | 0.52@500Ω | / | |
| Maximum PowerDensity,†† (W/cm2), (using smallestelectrode conductive surface area) | 0.0089@500Ω | 0.0033@500Ω | / | |
| Burst Mode(i.e., pulsetrains): | (a) Pulses per burst 1 | N/A | / | |
| ON Time (seconds) | 1~5 | Continuous | / | |
| OFF Time (seconds) | 1~5 | N/A | / | |
| Additional Features (specify, ifapplicable) | N/A | N/A | / |
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Note 03: based on K 153704, pulse width is acceptable within 70~300.
Note 04: subject device's pulses per burst rate is significantly higher than the predicate device in Table 03-1 to Table 03-9 and significantly less in Table 03-10, but the duty cycle of the subject device is same as the duty cycle of the predicate, so the differences do not affect safety and effectiveness of the subject device.
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Note 05: based on K162517, Mode P1 cycles the mode 28, therefore, the maximum parameters do not appear at the same time. For example, in all 8 modes, the Maximum Output Voltage is 134V@10 kΩ, which is in mode P2 (K162517), but in mode P2, the corresponding Maximum Power Density is 0.92@500Ω , which is not maximum in all 8 modes. Nevertheless, the maximum parameters will not exceed the range of mode 28, similarly, P15 of subject device can be customized within the parameters of its P1-P14. So, P15 of subject device is SE to P1 of K162517 when P1,P2....P14 is respectively SE to mode P2,P3...P7.
5.7 Brief discussion of the nonclinical tests
The subject device conforms to the following standards: IEC 60601-1:2005+CORR.1:2006+CORR.2007+A1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.
60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General IEC Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
IEC 60601-1-11:2015 Medical Electrical Equipment - Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment
IEC 60601-2-10:2016 Medical Electrical Equipment - Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators
ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.
ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization.
5.8 Brief discussion of clinical tests N/A.
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5.9 Other information (such as required by FDA guidance/Test) No.
5.10 Conclusions
The subject devices have all features of the predicate device. The few differences do not affect the safety and effectiveness of the subject devices.
Thus, the subject device is substantially equivalent to the predicate device.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).