(271 days)
To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (Choose Mode B or C).
To stimulate healthy muscles in order to improve and facilitate muscle performance (Choose Mode A).
To temporarily increase local blood circulation in healthy muscles (Choose Mode A).
Pain Therapy Device is a household multifunctional device, it can stimulate healthy muscles in order to improve and facilitate muscle performance, and temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Pain Therapy Device has three operation modes and two channels, which can give certain electrical pulse through 2 pairs of electrode pads on the skin.
The electronic stimulatory main units have the operating elements of ON/OFF knob, Mode Selection key and Time Selection key which can be user-friendly controlled.
The device is equipped with accessories of electrode pads and an electrode wire. The electrode wire is used to connect the pads to the main unit. All the accessories can only be changed by local distributor. "Large Patch Electrode" and "Small Patch Electrode" are cleared in K090198.
"Insole Electrode", "Sole Plant Electrode A" and "Sole Plant Electrode B" are cleared in K151693.
The provided document is a 510(k) Summary for a Pain Therapy Device (K163611). It primarily focuses on demonstrating substantial equivalence to predicate devices based on safety and performance through bench testing and comparison of technical specifications.
Therefore, it does not describe acceptance criteria for a study demonstrating device performance against specific targets, nor does it detail a clinical study with human subjects, ground truth establishment, or multi-reader multi-case analyses.
The document outlines the following information relevant to the device's validation:
1. A table of acceptance criteria and the reported device performance:
The document does not present a table of specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) and the device's reported performance against those. Instead, it demonstrates compliance with recognized standards and substantial equivalence to predicate devices through technical specifications.
The "Test Summary" section (page 4) lists the following tests and their compliance:
| Acceptance Criterion (Standard Compliance) | Reported Device Performance |
|---|---|
| Electrical safety (IEC 60601-1 and IEC 60601-2-10) | Complies |
| Electromagnetic compatibility (IEC 60601-1-2) | Complies |
| Biocompatibility (ISO 10993-5 and ISO 10993-10) | Complies (all user directly contacting materials) |
| Usability (IEC 62366) | Complies |
| Software verification and validation (FDA Guidance for Software in Medical Devices) | Complies |
| Electrode wire compliance (21 CFR 898 by IEC 60601-1 version 3.1, clause 8.5.2.3) | Complies |
The "Comparison to predicate device and conclusion" tables (pages 5-12) provide a detailed comparison of the subject device's technical specifications and intended uses against three predicate devices. The "Remark" column consistently states "SE" (Substantially Equivalent), indicating that the subject device's performance characteristics are considered equivalent to those of the legally marketed predicate devices, and that differences do not raise new issues of safety or effectiveness.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not Applicable. The provided document does not describe a clinical study involving a test set, human subjects, or data provenance in the context of device performance. The testing was primarily bench testing to ensure compliance with standards and equivalence to predicate devices.
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):
Not Applicable. As no clinical study or test involving human subjects with a "ground truth" was described, this information is not present. The "ground truth" for the technical comparisons is rooted in the specifications and regulatory clearances of the predicate devices and the relevant international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not Applicable. No clinical test set or adjudication method is described.
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 is a Pain Therapy Device (Transcutaneous Electrical Nerve Stimulator, TENS/EMS). It is not an AI-powered diagnostic imaging device or similar system where "human readers" or "AI assistance" would apply. Therefore, no MRMC study was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not Applicable. This is a hardware medical device; the concept of "standalone algorithm performance" is not relevant in the context of this 510(k) submission. The "software verification and validation test" mentioned (page 4) refers to the embedded software within the device and its compliance with FDA guidance, not a standalone algorithm for diagnostic or interpretative purposes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not Applicable. For a device of this type, demonstrating "substantial equivalence" relies on technical specifications, safety testing (electrical, EMC, biocompatibility, usability), and comparison of intended use to legally marketed predicate devices. The "ground truth" for this regulatory submission is compliance with established standards and the characteristics of the predicate devices. There is no mention of clinical outcomes data in the sense of a dedicated clinical trial to establish efficacy against a "ground truth" condition.
8. The sample size for the training set:
Not Applicable. The document does not describe the development or training of an AI algorithm, therefore, no training set or its sample size is mentioned.
9. How the ground truth for the training set was established:
Not Applicable. As there is no training set for an AI algorithm, this information is not provided.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines that resemble a ribbon or banner beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 19, 2017
Guangzhou Xinbo Electronic Co., Ltd. % Ms. Cecilia Ceng Manager Guangzhou Glomed Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, Guangdong 510000 CN
Re: K163611
Trade/Device Name: Pain Therapy Device Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief, Over The Counter Regulatory Class: Class II Product Code: NUH, NYN, NGX Dated: August 3. 2017 Received: August 9, 2017
Dear Ms. Ceng:
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. 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.
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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Vivek J. Pinto -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K163611
Device Name Pain Therapy Device
Indications for Use (Describe)
To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (Choose Mode B or C).
To stimulate healthy muscles in order to improve and facilitate muscle performance (Choose Mode A).
To temporarily increase local blood circulation in healthy muscles (Choose Mode A).
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 201 Subpart D) | ☐ |
|---|---|
| Over-The-Counter Use (21 CFR 201 Subpart C) | ☑ |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Chapter 5. 510(k) Summary
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.
1. Submitter's Information
510(k) Owner's Name: Guangzhou Xinbo Electronic Co., Ltd. Establishment Registration Number: Applying Address: 2nd Building, Juntuo Industry Park, Xingye Dadao, Nancun Town, Panyu District, Guangzhou City, Guangdong Province, China Tel: +86-020-66393598 Fax: +86-020-34822409 Contact Person: Li Huifang (Manger) Email: drtvsammy@hotmail.com
Application Correspondent:
Contact Person: Ms. Cecilia Ceng / Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663, China Tel: +86-20-61099984 Email: regulatory@glomed-info.com
2. Subject Device Information
Trade Name: Pain Therapy Device Common Name: Electronic Stimulator Classification name: Transcutaneous electrical nerve stimulator for pain relief Review Panel: Neurology, Physical Medicine Product Code: NUH, NYN, NGX Regulation Class: II Regulation Number: 882.5890, 890.5850
3. Predicate Device Information
| Sponsor | Shenzhen OSTOTechnology CompanyLimited | Actegy, Ltd. | Counter ScientificDevelopment (GZ) Ltd. |
|---|---|---|---|
| Device Nameand Model | Health Expert ElectronicStimulator, Models: AST-300C and AST-300D | Revitive IX (OTC), Model:MT1101 | Pain Therapy System,Model: PTS-II |
| 510(k) | K133929 | K143207 | K150277 |
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| Sponsor: | Guangzhou Xinbo Electronic Co., Ltd. |
|---|---|
| Subject Device: | Pain Therapy Device, Models: P.T.S-II, P.T.S-IIA, P.T.S-IIB, CP-II |
| Document Name: | FDA 510(k) Submission Report |
| Number | (Primary Predicate) | ||
|---|---|---|---|
| Product Code | NUH, NGX | NUH, NGX | NUH, NGX, NYN, GZJ |
| RegulationNumber | 882.5890, 890.5850 | 882.5890, 890.5850 | 882.5890, 890.5850 |
| RegulationClass | II | II | II |
4. Device Description
Pain Therapy Device is a household multifunctional device, it can stimulate healthy muscles in order to improve and facilitate muscle performance, and temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Pain Therapy Device has three operation modes and two channels, which can give certain electrical pulse through 2 pairs of electrode pads on the skin.
The electronic stimulatory main units have the operating elements of ON/OFF knob, Mode Selection key and Time Selection key which can be user-friendly controlled.
The device is equipped with accessories of electrode pads and an electrode wire. The electrode wire is used to connect the pads to the main unit. All the accessories can only be changed by local distributor. "Large Patch Electrode" and "Small Patch Electrode" are cleared in K090198.
"Insole Electrode", "Sole Plant Electrode A" and "Sole Plant Electrode B" are cleared in K151693.
5. Intended Use / Indications for Use
To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet), due to strain from exercise or normal household work activities by applying current to stimulate nerve. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (Choose Mode B or C).
To stimulate healthy muscles in order to improve and facilitate muscle performance (Choose Mode A). To temporarily increase local blood circulation in healthy muscles (Choose Mode A).
6. Test Summary
Pain Therapy Device has been evaluated the safety and performance by lab bench testing as following:
- � Electrical safety test according to IEC 60601-1 and IEC 60601-2-10 standards
- � Electromagnetic compatibility test according to IEC 60601-1-2 standard
- � Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- � Usability test according to IEC 62366 standard
- � Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
- � The electrode wire is compliance with 21 CFR 898 by IEC 60601-1 (version 3.1, clause 8.5.2.3) evaluation.
{5}------------------------------------------------
| Sponsor: | Guangzhou Xinbo Electronic Co., Ltd. |
|---|---|
| Subject Device: | Pain Therapy Device, Models: P.T.S-II, P.T.S-IIA, P.T.S-IIB, CP-I |
| Document Name: | FDA 510(k) Submission Report |
7. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, mode of operation, and intended use of Electronic Muscle Stimulator 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 | Predicate Device | Predicate Device | Remark | |
|---|---|---|---|---|---|
| Device Nameand Model | Pain TherapyDevice, Models:P.T.S-II, P.T.S-IIA,P.T.S-IIB, CP-I | Health ExpertElectronicStimulatorModels: AST-300Cand AST-300D | Revitive IX (OTC),Model: MT1101 | Pain TherapySystem,Model: PTS-II(Primary Predicate) | -- |
| 510(k) Number | K163611 | K133929 | K143207 | K150277 | -- |
| Intended Use &Indications forUse | 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) dueto strain fromexercise or normalhousehold workactivities by applyingcurrent to stimulatenerve.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 | PMS (Mode 1 | To temporarilyincrease local bloodcirculation in healthyleg muscles.To stimulate healthymuscles in order toimprove andfacilitate muscleperformance.For temporary reliefof pain associatedwith sore and achingmuscles in theshoulder, waist,back, upperextremities (arms)and lowerextremities (legs)due to strain fromexercise or normalhousehold duties. | To be used fortemporary relief ofpain associated withsore and achingmuscles in the upperand lower back dueto strain fromexercise or normalhousehold workactivities (ChooseMode A, B, or C).To be used fortemporary relief ofpain associated withsore and achingmuscles in the upperextremities (Arms)due to strain fromexercise or normalhousehold workactivities (ChooseMode A, B or C).To be used fortemporary relief ofpain associated withsore and achingmuscles in the lowerextremities (Legs)due to strain fromexercise or normalhousehold workactivities (ChooseMode A, B or C).To be used for | SENote 4 |
{6}------------------------------------------------
| Sponsor: | Guangzhou Xinbo Electronic Co., Ltd. |
|---|---|
| Subject Device: | Pain Therapy Device, Models: P.T.S-II, P.T.S-IIA, P.T.S-IIB, CP-I |
| Document Name: | FDA 510(k) Submission Report |
| Elements ofComparison | Subject Device | Predicate Device | Remark | ||
|---|---|---|---|---|---|
| circulation in healthymuscles (ChooseMode A). | symptomatic reliefand management ofchronic, intractablepain and relief ofpain associated withArthritis (ChooseMode A).To stimulate healthymuscles in order toimprove andfacilitate muscleperformance(Choose Mode B). | ||||
| OTC or Rx | OTC | OTC | SE | ||
| Basic Unit Characteristics | |||||
| PowerSource(s) | DC 3.0V, 2 x AAA | Adaptor Input: 100-240Vac, 50-60Hz,0.1AMain Unit Input:5Vdc, 1A | Adaptor Input: 100-240Vac, 50/60Hz,0.18AMain Unit Input:5.0Vdc, 1.0A | DC 3.0V, 2 x AAA | SE |
| Method of LineCurrent Isolation | Type BF AppliedPart | Type BF AppliedPart | -- | SE | |
| PatientLeakageCurrent | NC | DC: 0.5 μΑ | AC: 54.5 μΑ,DC: 0.5 μΑ | -- | SENote 1 |
| SFC | DC: 0.6 μΑ | AC: 120.0 μΑ,DC: 0.6 μΑ | -- | ||
| Average DCcurrent throughelectrodes whendevice is on butno pulses arebeing applied | < 0.01 μA | < 0.01 μA | -- | SE | |
| Number ofOutputChannels | 2 Channels: formodels P.T.S-II,P.T.S-IIA, P.T.S-IIB;1 Channel: formodel CP-I | 2 | 2 | SENote 1 | |
| Number ofOutput Modes | 3 | 25 | 1 | SE | |
| Output IntensityLevel | 5 steps | 99 steps | -- | SE | |
| Synchronous orAlternating? | Synchronous | Synchronous | -- | SE |
{7}------------------------------------------------
| Sponsor: | Guangzhou Xinbo Electronic Co., Ltd. |
|---|---|
| Subject Device: | Pain Therapy Device, Models: P.T.S-II, P.T.S-IIA, P.T.S-IIB, CP- |
| Document Name: | FDA 510(k) Submission Report |
| Elements ofComparison | Subject Device | Predicate Device | Predicate Device | Remark |
|---|---|---|---|---|
| Method ofChannelIsolation | Parallel connection | -- | Parallel connection | SE |
| RegulatedCurrent orRegulatedVoltage? | Regulated Voltage | Regulated Voltage | Regulated Voltage | SE |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | SE |
| AutomaticOverload Trip | No | -- | No | SE |
| Automatic No-Load Trip | No | -- | No | SE |
| Automatic ShutOff | Yes | -- | Yes | SE |
| User OverrideControl | Yes | -- | Yes | SE |
| IndicatorDisplay | On/OffStatus | Yes | Yes | SE |
| LowBattery | No | -- | No | SE |
| Voltage/Current Level | Yes | -- | Yes | SE |
| Timer Range | 10, 20, 40 min | 25 min | 1 to 60 min | SE |
| Weight | Main Unit:P.T.S-II: 75gP.T.S-IIA: 100gP.T.S-IIB: 100gCP-I: 66gElectrode:Big Patch Electrode:40gSmall PatchElectrode: 10gInsole Electrode:200gSole Plant ElectrodeA (only for CP-I):900gSole Plant Electrode | 2kg (Withoutaccessories) | 1.725kg (WithoutPSU) | SENote 2 |
{8}------------------------------------------------
| Sponsor: | Guangzhou Xinbo Electronic Co., Ltd. |
|---|---|
| Subject Device: | Pain Therapy Device, Models: P.T.S-II, P.T.S-IIA, P.T.S-IIB, CP-I |
| Document Name: | FDA 510(k) Submission Report |
| Elements ofComparison | Subject Device | Predicate Device | Remark | ||
|---|---|---|---|---|---|
| B: 920g | |||||
| Dimensions | Main Unit:P.T.S-II: 110 x 78 x 20 mmP.T.S-IIA: 135 x 82 x 20 mmP.T.S-IIB: 135 x 82 x 20 mmCP-I: 92 x 78 x 20 mmElectrode:Large PatchElectrode: 120 x 80 mmSmall PatchElectrode: 46 x 46 mmInsole Electrode:260 x 110 mmSole Plant Electrode A (only for CP-I):450 x 450 x 90 mmSole Plant Electrode B:450 x 450 x 90 mm | 428mm x 428.8mmx 185mm | Ø360mm x 75mm | 110 x 78 x 20 mm | SENote 2 |
| HousingMaterials andConstruction | Main unit: ABSplastic | Main unit: ABSplastic | Casing/body: ABS,Footpads: NBR | Main unit: ABSplastic | SE |
| Output Specifications | |||||
| Waveform | Pulsed, symmetric, biphasic | Pulsed, symmetric, biphasic | Pulsed, symmetric, biphasic | Positive-going,Reverse | SE |
| Shape | Rectangular, with interphase interval | Rectangular, with interphase interval | Rectangular and bipolar | Square wave | SE |
| MaximumOutput Voltage | 40Vp @ 500Ω | 44V±10% @ 500Ω | -- | 88Vp @ 500Ω | SE |
| 80Vp @ 2kΩ | 80V±10% @ 2kΩ | -- | 102Vp @ 2kΩ | SENote 3 | |
| 95Vp @ 10kΩ | 112V±10% @ 10kΩ | -- | 106Vp @ 10kΩ | ||
| MaximumOutput Current | 80mA @ 500Ω | 88mA±10% @ 500Ω | -- | 176mA @ 500Ω | SENote 3 |
| 40mA @ 2kΩ | 40mA±10% @ 2kΩ | -- | 51.0mA @ 2kΩ | ||
| 9.5mA @ 10kΩ | 11.2mA±10% @10kΩ | -- | 10.6mA @ 10kΩ | ||
| Pulse Duration | 200µs | 120µs | -- | 170µs | SENote 3 |
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| Sponsor: | Guangzhou Xinbo Electronic Co., Ltd. |
|---|---|
| Subject Device: | Pain Therapy Device, Models: P.T.S-II, P.T.S-IIA, P.T.S-IIB, CP- |
| Document Name: | FDA 510(k) Submission Report |
| Elements ofComparison | Subject Device | Predicate Device | Remark | ||
|---|---|---|---|---|---|
| Pulse frequency | 13.7~48.5 Hz | 77.3Hz | -- | SENote 3 | |
| Net Charge (perpulse) | 0µC @ 500Ω,Method: Balancedwaveform | 0µC @ 500Ω,Method: Balancedwaveform | -- | 1.63µC @ 500Ω | SENote 3 |
| MaximumPhase Charge | 19.2µC @ 500Ω | 12.78µC @ 500Ω | -- | 29.9µC @ 500Ω | SENote 3 |
| MaximumAverage Current | 1.53mA @ 500Ω | 0.968mA @ 500Ω | -- | 2.22mA | SENote 3 |
| MaximumCurrent Density(r.m.s) | 0.073mA/cm² @500Ω | 0.235mA/cm² @500Ω | -- | 8.31mA/cm² @ 500Ω | SENote 3 |
| MaximumAverage PowerDensity | 0.056mW/cm² @500Ω | 1.38mW/cm² @500Ω | -- | 0.115mW/cm² @500Ω | SENote 3 |
| ON Time | 2s | 0.6s | -- | -- | SENote 3 |
| OFF Time | 2s | 0.6s | -- | -- | SENote 3 |
| Additional Features | |||||
| OperatingEnvironment | Temperature:5 | Temperature:5 | -- | -- | SENote 1 |
| StorageEnvironment | Temperature:Main Unit: -20 | Temperature:0 | -- | -- | SENote 1 |
| Standards | |||||
| Biocompatibility | All user directlycontacting materialsare compliance withISO10993-5 andISO10993-10requirements. | All user directlycontacting materialsare compliance withISO10993-5 andISO10993-10requirements. | All user directlycontacting materialsare compliance withISO10993-5 andISO10993-10requirements. | All user directlycontacting materialsare compliance withISO10993-5 andISO10993-10requirements. | SE |
{10}------------------------------------------------
| Sponsor: | Guangzhou Xinbo Electronic Co., Ltd. |
|---|---|
| Subject Device: | Pain Therapy Device, Models: P.T.S-II, P.T.S-IIA, P.T.S-IIB, CP-I |
| Document Name: | FDA 510(k) Submission Report |
| Elements ofComparison | Subject Device | Predicate Device | Remark | |
|---|---|---|---|---|
| Electrode" and"Small PatchElectrode" arecleared in K090198."Insole Electrode","Sole PlantElectrode A" and"Sole PlantElectrode B" arecleared in K151693. | ||||
| Electrical Safety | Comply with IEC60601-1 and IEC60601-2-10 | Comply with IEC60601-1 and IEC60601-2-10 | Comply with IEC60601-1 and IEC60601-2-10 | SE |
| EMC | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 | SE |
Comparison in Detail(s):
Note 1:
Although the "Patient Leakage Current". "Number of Output Channels". "Operating Environment", and "Storage Environment" are a little different from the predicate devices, they all comply with IEC 60601-1 requirements. So the differences will not raise any safety or effectiveness issue.
Note 2:
Although the "Weight" and "Dimensions" of subject device are different from the predicate devices, they 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 3:
Although some output specifications "Maximum Output Voltage", "Maximum Output Current", "Pulse Duration", "Maximum Pulse Frequency", "Net Charge (per pulse)", "Maximum Phase Charge", "Maximum Average Current", "Maximum Current Density", "Maximum Average Power Density of subject device", "ON Time" and "OFF Time" are a little different from the predicate devices, they all comply with IEC 60601-1, IEC 60601-2-10 requirement, FDA guidance requirement for Transcutaneous Electrical Nerve Stimulator for Pain Relief and FDA guidance requirement for Powered Muscle Stimulator for Muscle Conditioning. So the differences of function specification will not raise any safety or effectiveness issue.
Note 4:
Although the Indication for Use (IFU) of subject device is a little different from that of predicate, its combines from 3 predicate devices' IFU, so the differences between them will not raise any safety or effectiveness issue.
Additional Modes Comparison Table:
| Elements ofComparison | Subject Device (K163611) | Predicate Device (K133929) | Remark |
|---|---|---|---|
| --------------------------- | -------------------------- | ---------------------------- | -------- |
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| Sponsor: | Guangzhou Xinbo Electronic Co., Ltd. |
|---|---|
| Subject Device: | Pain Therapy Device, Models: P.T.S-II, P.T.S-IIA, P.T.S-IIB, CP- |
| Document Name: | FDA 510(k) Submission Report |
| Elements ofComparison | Subject Device (K163611) | Predicate Device (K133929) | Remark |
|---|---|---|---|
| Device Name | Pain Therapy Device, Models:P.T.S-II, P.T.S-IIA, P.T.S-IIB, CP-I | Health Expert Electronic Stimulator | -- |
| Mode ComparisonGroup 1 | Mode A | Mode 2 | -- |
| - Indications for UseClaim | PMS claims | PMS claims | SE |
| - Waveform | Pulsed, Rectangular, Symmetric,Biphasic | Pulsed, Rectangular, Symmetric,Biphasic | SE |
| - Pulse Width | 200μs | 120μs | SENote (a) |
| - Pulse Frequency | 48.5Hz | 77.3Hz | SENote (a) |
| - Pulse CycleNumber (T) for OneBurst | 200T ~ 206T | 200T | SENote (a) |
| - Maximum OutputVoltage | 40Vpk @ 500Ω80Vpk @ 2kΩ95Vpk @ 10kΩ | 44Vpk @ 500Ω80Vpk @ 2kΩ112Vpk @ 10kΩ | SENote (b) |
| Mode ComparisonGroup 2 | Mode B | Mode 20 | -- |
| - Intended Use Claim | TENS claims | TENS claims | SE |
| - Waveform | Pulsed, Rectangular, Symmetric,Biphasic | Pulsed, Rectangular, Symmetric,Biphasic | SE |
| - Pulse Width | 200μs | 120μs | SENote (a) |
| - Pulse Frequency | 13.7Hz / 19.0Hz | 77.3Hz | SENote (a) |
| - Pulse CycleNumber (T) for OneBurst | 82T ~ 113T | 100T | SENote (a) |
| - Maximum OutputVoltage | 40Vpk @ 500Ω80Vpk @ 2kΩ95Vpk @ 10kΩ | 44Vpk @ 500Ω80Vpk @ 2kΩ112Vpk @ 10kΩ | SENote (b) |
| Mode ComparisonGroup 3 | Mode C | Mode 14 | -- |
| - Intended Use Claim | TENS claims | TENS claims | SE |
| - Waveform | Pulsed, Rectangular, Symmetric,Biphasic | Pulsed, Rectangular, Symmetric,Biphasic | SE |
| - Pulse Width | 200μs | 120μs | SENote (a) |
| - Pulse Frequency | 46.1Hz / 38.6Hz / 29.4Hz | 77.3Hz | SENote (a) |
| - Pulse Cycle | 150T ~ 184T | 200T | SE |
{12}------------------------------------------------
| Sponsor: | Guangzhou Xinbo Electronic Co., Ltd. |
|---|---|
| Subject Device: | Pain Therapy Device, Models: P.T.S-II, P.T.S-IIA, P.T.S-IIB, CP-I |
| Document Name: | FDA 510(k) Submission Report |
| Elements ofComparison | Subject Device (K163611) | Predicate Device (K133929) | Remark |
|---|---|---|---|
| Number (T) for OneBurst | Note (a) | ||
| - Maximum OutputVoltage | 40Vpk @ 500Ω80Vpk @ 2kΩ95Vpk @ 10kΩ | 44Vpk @ 500Ω80Vpk @ 2kΩ112Vpk @ 10kΩ | SENote (b) |
Comparison in Detail(s):
Note (a):
Although the "Pulse Duration", "Pulse Frequency" and "Pulse Cycle Number for One Burst" of subject device are different from the predicate device, they are very similar in waveform group, 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 (b):
Although the "Maximum Output Voltage" of subject device is 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.
Finial Conclusion:
The subject device "Pain Therapy Device" is Substantial Equivalent to the predicate devices.
8. Date of the summary prepared: September 19, 2017
§ 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).