(428 days)
KTR-2210, KTR-2220, KTR-2230: (TENS, EMS, FITNESS)
TENS (Mode1~20): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
EMS (Mode 21~40): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. FITNESS (Mode 41-50): Improvement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen.
KTR-2211, KTR-2221, KTR-2231, KTR-2212, KTR-2222, KTR-2232: (TENS)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Low-frequency Multi-function physiotherapy instrument (Models: KTR-2210) is a portable and battery powered multifunctional device, offering Transcutaneous Electronic Nerve Stimulator (TENS), Electronic Muscle Stimulator (EMS) and FITNESS qualities.
Low-frequency Multi-function physiotherapy instrument (Models: KTR-2210) has 50 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body massage.
The electronic stimulatory module has the operating elements of ON/OFF Key, Display screen, Mode Selection key and Intensity Modification keys.
The LCD display screen can show selected mode and program, output intensity, stimulate frequency, and time remaining of an application mode.
The device is equipped with accessories of electrode wires, and batteries. The electrode wire is used to connect the patches to the main unit. All the accessories, including electrode pads, electrode wire, and batteries can only be changed by special person.
The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
The provided text describes a 510(k) premarket notification for a Low-frequency Multi-function physiotherapy instrument. This document primarily focuses on establishing substantial equivalence to predicate devices through a comparison of technical specifications and an assessment of safety and performance testing against recognized standards. It does not detail a study involving specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity) for an AI/CADe device, as the device itself is a physiotherapy instrument, not a diagnostic imaging AI.
Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test sets, expert qualifications, HRMC studies, standalone performance, ground truth establishment for training, etc.) are not applicable in this context.
However, I can extract the closest equivalents to acceptance criteria and reported "performance" based on the provided safety and performance tests.
Here's a breakdown of the information that can be extracted:
1. A table of acceptance criteria and the reported device performance
For a physiotherapy instrument, "acceptance criteria" relate to meeting safety and performance standards. The "reported device performance" is that the device complies with these standards.
| Acceptance Criteria (based on standards) | Reported Device Performance |
|---|---|
| Electrical Safety: IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10 | Complies with standards |
| Electromagnetic Compatibility: IEC 60601-1-2 | Complies with standard |
| Biocompatibility: ISO 10993-1, ISO 10993-5, ISO 10993-10 | Complies with standards (for all user-contacting materials) |
| Usability: IEC 62366-1 | Complies with standard |
| Software Verification & Validation: FDA Guidance for Pre-Market Submissions and for Software Contained in Medical Devices | Complies with FDA guidance |
| Waveform Test (Output Specifications): Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning | Complies with guidance; verifies output specifications |
| Patient Leakage Current: (e.g., < 0.01 µA) | Reported as < 0.01 µA (for Subject Device, similar to predicates) |
| Average DC current through electrodes (no pulses): (< 0.01 µA) | Reported as < 0.01 µA (for Subject Device, similar to predicates) |
| Maximum Output Voltage (e.g., @ 500 Ω, 2K Ω, 10K Ω) | 55V±10%@ 500 Ω; 75V±10% @ 2K Ω; 85V±10% @ 10K Ω |
| Maximum Output Current (e.g., @ 500 Ω, 2K Ω, 10K Ω) | 110mA±10% @ 500 Ω; 37.5mA±10% @ 2K Ω; 8.5mA±10% @ 10K Ω |
| Pulse Duration (TENS, EMS, FITNESS) | TENS: 120µs, EMS: 200µs, FITNESS: 200µs |
| Pulse frequency (TENS, EMS, FITNESS) | TENS:(20-100)Hz, EMS:(1-15)Hz, FITNESS:(2-16)Hz |
| Net Charge (per pulse) @ 500 Ω | 0µC (Balanced waveform) |
| Maximum Phase Charge @ 500 Ω | 15.97 µC |
| Maximum Average Current | 1.60mA |
| Maximum Current Density (r.m.s) @ 500 Ω | 0.064mA/cm² |
| Maximum Average Power Density | 0.08mW/cm² |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is primarily bench testing and compliance with standards, not a clinical trial with a "test set" of patients or data in the typical sense of AI/CADe validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. The device is a physiotherapy instrument, not a diagnostic device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication is typically for expert review of cases in diagnostic studies, which is not relevant here.
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
This information is not applicable/provided. The device is a therapeutic physiotherapy instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The device is not an algorithm for standalone performance assessment in the context of diagnostic AI. The "performance" assessment is about meeting electrical, EMC, biocompatibility, and output specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's acceptable performance is defined by compliance with established international and FDA-specific standards and guidances for electrical safety, electromagnetic compatibility, biocompatibility, usability, software, and waveform output specifications. This effectively serves as the "ground truth" for its safety and effectiveness for its intended use.
8. The sample size for the training set
This information is not applicable/provided. The document does not describe a training set for an AI/ML algorithm.
9. How the ground truth for the training set was established
This information is not applicable/provided. (See point 8)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 25, 2020
Shenzhen Kentro Medical Electronics Co., Ltd Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Room 2231, Building 1, Ruifeng Center, Kaichuang Road Huangpu District Guangzhou, Guangdong 51006 China
Re: K191982
Trade/Device Name: Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-222, KTR-2212) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: March 20, 2020 Received: June 29, 2020
Dear Cassie Lee:
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
{1}------------------------------------------------
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 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,
Heather Dean, PhD Assistant Director, Acute Injury Devices Team 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K191982
Device Name
Low-frequency Multi-function physiotherapy instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2211, KTR-2211, KTR-2232, KTR-2212)
Indications for Use (Describe)
KTR-2210, KTR-2220, KTR-2230: (TENS, EMS, FITNESS)
TENS (Model~20): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
EMS (Mode 21~40): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. FITNESS (Mode 41-50): Improvement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen.
KTR-2211, KTR-2221, KTR-2231, KTR-2212, KTR-2222, KTR-2232: (TENS)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
Submitter's Information 1.
- � 510(k) Owner's Name: Shenzhen Kentro Medical Electronics Co., Ltd
- � Establishment Registration Number: 3013671142
- Address: No.3, Xihu industry zone, Xikeng Village, Henggang Town, Longgang District, Shenzhen, � Guangdong, China
- � Tel: +86-755-33825998
- � Fax: +86-755-33825996
- Contact Person: Zewu Zhang (General Manger) �
- Email: kentro@kentro.com.cn �
2. Application Correspondent:
- Contact Person: Ms. Cassie Lee �
- � Guangzhou GLOMED Biological Technology Co., Ltd.
- � Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China
- Tel: +86 20 8266 2446 �
Email: regulatory@glomed-in fo.com
Subject Device Information 3.
- � Trade Name: Low-frequency Multi-function physiotherapy instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) Common Name: � Electronic Stimulator
- Stimulator, Nerve, Transcutaneous, Muscle, Powered, For � Classification name: Muscle Conditioning, Over-The-Counter
- � Review Panel: Neurology, Physical Medicine
- � Product Code: NUH, NGX
- � Regulation Class: ll
- Regulation Number: � 882.5890, 890.5850
4. Predicate Device Information
| Primary Predicate Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|
| Sponsor | Shenzhen OSTO TechnologyCompany Limited | Guangzhou Xinbo ElectronicCo., Ltd. | Shenzhen OSTOTechnology Co., Ltd. |
| Device | Health Expert Electronic | Pain Therapy Device | Intelligent Wireless FitnessApparatus |
{4}------------------------------------------------
| Name andModel | Stimulator, Model: AST-300Cand AST-300D | Models:P.T.S-11, P.T.S-IIA, P.T.S-118 , CP-I | Models: AST-301, AST-302,AST-303 |
|---|---|---|---|
| 510(k)Number | K133929 | K163611 | K182136 |
| ProductCode | NUH, NGX | NUH, NGX | NGX |
| RegulationNumber | 882.5890, 890.5850 | 882.5890, 890.5850 | 890.5850 |
| RegulationClass | II | II | II |
5. Device Description
Low-frequency Multi-function physiotherapy instrument (Models: KTR-2210) is a portable and battery powered multifunctional device, offering Transcutaneous Electronic Nerve Stimulator (TENS), Electronic Muscle Stimulator (EMS) and FITNESS qualities.
Low-frequency Multi-function physiotherapy instrument (Models: KTR-2210) has 50 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body massage.
The electronic stimulatory module has the operating elements of ON/OFF Key, Display screen, Mode Selection key and Intensity Modification keys.
The LCD display screen can show selected mode and program, output intensity, stimulate frequency, and time remaining of an application mode.
The device is equipped with accessories of electrode wires, and batteries. The electrode wire is used to connect the patches to the main unit. All the accessories, including electrode pads, electrode wire, and batteries can only be changed by special person.
The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
6. Intended Use / Indications for Use
KTR-2210, KTR-2220, KTR-2230: CTENS, EMS, FITNESS)
TENS (Mode1~20:) To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
EMS (Mode 21~40): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
FITNESS (Mode 41~50): Improvement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen.
KTR-2211, KTR-2221, KTR-2231, KTR-2212, KTR-2222, KTR-2232: (TENS)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
{5}------------------------------------------------
7. Test Summary
Low-frequency Multi-function physiotherapy instrument has been evaluated the safety and performance by lab bench testing as following:
- Electrical safety test according to IEC 60601-1, IEC 60601-1-11 and IEC 60601-2-10 standards
- Electromagnetic compatibility test according to IEC 60601-1-2 standard
- . Biocompatibility test according to ISO 10993-1, ISO 10993-5 and ISO 10993-10 standards
- Usability test according to IEC 62366-1 standard
- . Software verification and validation test according to the requirements of the FDA "Guidance for Pre-Market Submissions and for Software Contained in Medical Devices"
- . The waveform test report has also been conducted to verify the output specifications of the device according to Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning
8. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of Low-frequency Multi-function physiotherapy instrument is substantially equivalent to the predicate devices quoted above.
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements ofComparison | Subject Device | Primary PredicateDevice | Reference Device1 | ReferenceDevice 2 | Remark | |
|---|---|---|---|---|---|---|
| Device Name andModel | Low-frequency Multi-function physiotherapyinstrumentModel: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212 | Low-frequency Multi-function physiotherapyinstrumentModel: AST-300C andAST-300D | Pain TherapyDevice, Models:P.T.S-11, P.T.S-IIA,P.T.S-11B, CP-I | IntelligentWirelessFitnessApparatusModels: AST-301, AST-302,AST-303 | ||
| 510(k) Number | Applying | K133929 | K163611 | K182136 | ||
| Intended Use | KTR-2210 , KTR-2220 ,KTR-2230 : (TENS , EMS, FITNESS)TENS (Mode1~20): Tobe used for temporaryrelief of pain associatedwith sore and achingmuscles in the shoulder,waist, back, back of theneck, arm, leg, and footdue to strain fromexercise or normal | PMS (Mode 1 | To be used fortemporary relief ofpain associated withsore and achingmuscles in theupper and lowerback, back of theneck, upperextremities(shoulder and arm),lower extremities(leg and feet) due to | IntelligentWirelessFitnessApparatus isindicated to beused for:Improvementof abdominaltone,strengtheningof the | SENote 1 | |
| Elements ofComparison | Subject Device | Primary PredicateDevice | Reference Device1 | ReferenceDevice 2 | Remark | |
| household work activitiesby applying current tostimulate nerve.EMS (Mode 21 | back, back of the neck,arm, leg, and foot dueto strain from exerciseor normal householdwork activities byapplying current tostimulate nerve. | strain from exerciseor normalhousehold workactivities byapplying current tostimulate nerve.To be used forsymptomatic reliefand management ofchronic, intractablepain and relief ofpain associated witharthritis (ChooseMode B or C).To stimulate healthymuscles in order toimprove andfacilitate muscleperformance(Choose Mode A).To temporarilyincrease local blood | developmentof firmerabdomen.Strengthening,toning andfirming ofbuttocks andthighs. | |||
| Power Source(s) | DC 4.5V (3*AAA LR03battery), 180mA | Adaptor Input 100-240Vac, 50-60Hz,0.1AOutput 5Vdc, 1AUnit Input 5Vdc, 1A | DC 3.0V, 2 x AAA | Adapter(ModelHDMU05E-050100,HDMU05B-050100,HDMU05U-050100) Input100-240 Vac;50/60 Hz;0.3A; | SENote 2 | |
| Elements ofComparison | Subject Device | Primary PredicateDevice | Reference Device1 | ReferenceDevice 2 | Remark | |
| Output: 5 V;1 ARechargeableLithium-ionBattery:3.7Vdc | ||||||
| -Method of LineCurrent Isolation | Type BF Applied Part | Type BF Applied Part | Type BF Applied Part | Type BF Applied Part | SE | |
| PatientLeakageCurrent | NC | DC: 0.5μA | AC: 54.5µA,DC: 0.5μA | DC: 0.5µA | < 0 .01 µA | SE |
| SFC | DC: 0.6μA | AC:120.0 µ A , DC:0.6μA | DC: 0.6μA | 0.1mA | ||
| Average DCcurrent throughelectrodes whendevice is on butno pulses arebeing applied | < 0 .01 µA | < 0 .01μA | < 0 .01 | Not publiclyavailable | SE | |
| Number of OutputChannel s: | 2 channels | 2 | 2 | 2 | SE | |
| Number of OutputModes | 50 | 25 | 3 | 8 | SENote 3 | |
| Output IntensityLevel | 16 steps | 99 steps | 5 steps | Not publiclyavailable | SENote 3 | |
| Synchronous orAlternating? | Synchronous | Synchronous | Synchronous | Alternating | SE | |
| Method ofChannel Isolation | Voltage TransformIsolation"Ch1+" and "Ch1-"buttons for channel 1,"Ch2+" and "Ch2-"buttons for channel 2, | Voltage TransformIsolation" BodyT" and " Body T"buttons for bodychannel, "Sole .& " and"SoleT" buttons forfeet channel | Parallel connection | VoltageTransformIsolation | SENote 3 | |
| RegulatedCurrent orRegulatedVoltage? | Voltage Control | Voltage Control | Parallel connection | VoltageControl | SE | |
| Elements of Comparison | Subject Device | Primary Predicate Device | Reference Device 1 | Reference Device 2 | Remark | |
| Software/Fi rmware/Microprocessor Control? | Yes | Yes | Yes | Yes | SE | |
| Automatic Overload Trip | No | No | No | No | SE | |
| Automatic No-Load Trip | No | No | No | No | SE | |
| Automatic Shut Off | Yes | Yes | Yes | Yes | SE | |
| User Override Control | Yes | Yes | Yes | Yes | SE | |
| Indicator Display | On/Off Status | Yes | Yes | Yes | Yes | SE |
| Low Battery | No | No | No | Yes | SE | |
| Voltage/Current Level | Yes | Yes | Yes | Yes | SE | |
| Timer Range | 15, 30, 45min | 25min | 10, 20, 40 min | 15 min | SE Note 3 | |
| Weight | KTR-2210, KTR-2211, KTR-2212: 76gKTR-2220, KTR-2221, KTR-2222: 82gKTR-2230, KTR-2231, KTR-2232: 75gElectrode :12gElectrode wire: 12g | 2Kg (Without accessories) | Main Unit:P.T.S-11: 75gP.T.S-IIA: 100gP.T.S-11B: 100gCP-I: 66gElectrode:Big Patch Electrode: 40gSmall Patch Electrode:10gInsole Electrode: 200gSole Plant Electrode A (only for CP-I): 900gSole Plant | 80g (Without accessories) | SE Note 4 | |
| Elements ofComparison | Subject Device | Primary PredicateDevice | Reference Device1 | ReferenceDevice 2 | Remark | |
| Electrode B: 920g | ||||||
| Dimensions | Main unit:KTR 2210, KTR-2211,KTR-2212:122mm * 55mm *21.8mm;KTR-2220 , KTR-2221 ,KTR-2222 , KTR-2230 ,KTR-2231 and KTR-2232:120mm * 55mm *20.4mmElectrode:Square shape: 50mm x50mm (Area: 25cm $^{2}$ )Irregularly shape: about50mm x 70mm (Area:about 30cm $^{2}$ ) | 428mm x 428.8mm x185mm | Main Unit:P.T.S-11: 110 x 78 x20mmP.T.S-IIA: 135 x 82x20 mmP.T.S-IIB: 135 x 82x20 mmCP-I: 92 x 78 x 20mmElectrode:Large PatchElectrode: 120 x 80mmSmall PatchElectrode: 46 x 46mmInsole Electrode:260 x 110 mmSole PlantElectrodeA (only for CP-I):450 x 450 x 90 mmSole PlantElectrode B: 450 x450 x 90 mm | Main Unit:50X37mmElectrode padfor model AST-301: 198mm x164mm x 2mmElectrode padfor model AST-302: 192mm x164mm x 2mmElectrode padfor model AST-303: 125 mm x80mm x2mmEach gel sheet90mm x60mmx2mm | SENote 4 | |
| Housing Materialsand Construction | Mam urnt: ABS plastic | Main unit: ABS plastic | Main unit: ABSplastic | Main unit: ABSplastic | SE | |
| Waveform | Pulsed, symmetric,biphasic | Pulsed, symmetric,biphasic | Pulsed, symmetric,biphasic | Pulsed,Symmetrical,Biphasic | SE | |
| Shape | Rectangular , withinterphase interval | Rectangular , withinterphase interval | Rectangular | Rectangular ,with interphaseinterval | SE | |
| Maximum Output | 55V±10%@ 500 Ω | 44V±10% @ 500 Ω | 40V±10% @ 500 Ω | 44V±10%@500 Ω | SE | |
| Voltage | 75V±10% @ 2K Ω | 80V±10% @ 2K Ω | 80V±10% @ 2K Ω | 80V±10%@2K Ω | Note 3 | |
| Elements ofComparison | Subject Device | Primary PredicateDevice | Reference Device1 | ReferenceDevice 2 | Remark | |
| $85V±10% @ 10K Ω$ | $112V±20% @ 10K Ω$ | $95V±10% @ 10K Ω$ | $112V± 20 % @ 10K Ω$ | |||
| Maximum OutputCurrent | $110mA±10% @ 500 Ω$ | $88mA±10% @ 500 Ω$ | $80mA±10% @ 500 Ω$ | $88mA±10% @ 500 Ω$ | SENote 3 | |
| $37.5mA±10% @ 2K Ω$ | $40mA±10% @ 2K Ω$ | $40mA±10% @ 2K Ω$ | $40mA±10%@2K Ω$ | |||
| $8.5mA±10% @ 10K Ω$ | $11.2mA±10% @ 10K Ω$ | $9.5mA±10% @10K Ω$ | $11.2mA±10% @10K Ω$ | |||
| Pulse Duration | TENS: 120µs, EMS:200µs, FITNESS: 200µs | 120µs | 200µs | 120µs | SENote 3 | |
| Pulse frequency | TENS:(20-100)Hz,EMS:(1-15)Hz,FITNESS:(2-16)Hz | 77.3Hz | 13.7~48.5Hz | 8.33Hz | SENote 3 | |
| Net Charge (perpulse) | 0µC @500 ΩMethod: Balancedwaveform | 0µC @500 ΩMethod: Balancedwaveform | 0µC @ 500 Ω,Method: Balancedwaveform | 10.56µC @500Ω | SE | |
| Maximum PhaseCharge | 15.97 µC @ 500 Ω | 12.78µC @ 500 Ω | 19.2µC @ 500 Ω | 12.78µC @500Ω | SENote 3 | |
| MaximumAverage Current | 1.60mA | 0.968mA @ 500 Ω | 1.53mA @ 500 Ω | 1.69mA @500 Ω | SENote 3 | |
| Maximum CurrentDensity(r.m.s) | 0.064mA/cm² @ 500 Ω | 0.235mA/cm² @500 Ω | 0.073mA/cm²@500 Ω | 0.26 mA/cm²@500 Ω | SENote 3 | |
| MaximumAverage PowerDensity | 0.08mW/cm² | 1.38mW/cm² @ 500 Ω | 0.056mW/cm²@500 Ω | 15.37µW/cm²@500 Ω | SENote 3 | |
| ON Time | 0.6s | 0.6s | 2s | 3s | SE | |
| OFF Time | 0.6s | 0.6s | 23s | 3s | SE | |
| Environment foroperating | Environmenttemperature : +5°C-+40 C;Environment humidity:15%-93%RH | Temperature: 5 ~ 45°CHumidity: 20 ~ 65%RH | Temperature5~40°C,Humidity: ::;a0 %RH, 0°C to +40°CAtmosphericPressure: | SENote 5 | ||
| Elements ofComparison | Subject Device | Primary PredicateDevice | Reference Device1 | ReferenceDevice 2 | Remark | |
| Atmosphericenvironment conditions:700hPa-1060hPa | 86~106kPa | |||||
| Environment forstorage | Environmenttemperature: -25°C-+70°C; Environmenthumidity: 0-93%RH;Atmosphericenvironment conditions:700hPa-1060hPa. | Temperature: 0 | Temperature:Main Unit: -20 | Not publiclyavailable | SENote 5 | |
| Biocompatibility | All user directlycontacting materials arecompliance withISO10993-5 andISO10993-10requirements. | All user directlycontacting materialsare compliance withISO10993-5 andISO10993-10requirements. | Allus e_r directly.contacting materialsare compliance withISO10993-5 andISO10993-10requirements. | All user directlycontactingmaterials arecompliancewith ISO10993-5 andISO 10993-10requirements. | SE | |
| Electrical Safety | Comply with IEC 60601-1 and IEC 60601-2-10 | Comply with IEC60601-1 and IEC60601 2 10 | Comply with IEC60601-1 and IEC60601-2-10 | Comply withIEC 60601-1and 60601-2-10 | SE | |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 | Comply withIEC 60601-1-2 | SE |
{6}------------------------------------------------
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
Comparison in Detail(s):
Note 1:
Although the "intended use" are a little different from the predicate device, but the Indications and applicable parts are same, and the differences will not raise any safety or effectiveness issue.
Note 2:
Although the "power source" is a little different from the predicate device, they are all comply with IEC 60601-1 and IEC 60601-2-10 requirements, and the differences will not raise any safety or effectiveness issue.
Note 3:
{12}------------------------------------------------
Although the "Number of Output Modes", "Output Intensity Level "," Method of Channel Isolation", "Timer Range", "Maximum Output Voltage", "Maximum Output Current", "Pulse Duration", "Pulse frequency", "Maximum Phase Charge', "Maximum Average Current ', "Maximum Current Density(r.m.s )', and "Maximum Average Power Density", of subject device are little different from the predicate device, their maximum peak voltage are very similar, and are all comply with IEC 60601-1 and IEC 60601-2-10 requirements. So the differences of the function specifications will not raise any safety or effectiveness issue.
Note 4:
Although the "Weight" and "Dimensions" are a little different from the predicate device, but the differences will not raise any safety or effectiveness issue.
Note 5: Although the "Environment for operating" and "Environment for storage s" are a little different from the predicate device, but the differences will not raise any safety or effectiveness issue.
Finial Conclusion:
The subject devices "Low-frequency Multi-function physiotherapy instrument , model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2211, KTR-2211, KTR-2232, KTR-2222, KTR-2212" are Substantial Equivalent to the predicate device K133929. For the differ pulse duration of 200us, the subject device are compared with the reference device K163611, and there is no any safety or effectiveness issue.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).