Who is the manufacturer of Pain Therapy Device?

Guangzhou Xinbo Electronic Co., Ltd. filed the 510(k) submission for Pain Therapy Device (K163611).

What is the FDA product code for Pain Therapy Device?

NUH. It is classified under 21 CFR 882.5890 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Pain Therapy Device?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Pain Therapy Device?

Health Expert Electronic Stimulator, Models: AST-300C and AST-300D (K133929); Revitive IX (OTC), Model: MT1101 (K143207); Pain Therapy System, Model: PTS-II (K150277).

Who can help prepare an FDA 510(k) submission like Pain Therapy Device?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Pain Therapy Device

K163611 · Guangzhou Xinbo Electronic Co., Ltd. · NUH · Sep 19, 2017 · Neurology

Device Facts

Record ID	K163611
Device Name	Pain Therapy Device
Applicant	Guangzhou Xinbo Electronic Co., Ltd.
Product Code	NUH · Neurology
Decision Date	Sep 19, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5890
Device Class	Class 2
Attributes	Therapeutic

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).

Device Story

Pain Therapy Device is a household multifunctional electronic stimulator; uses two channels to deliver electrical pulses via electrode pads to skin. Device features three operation modes (A, B, C) and user-controlled settings (ON/OFF, Mode, Time). Input: user-selected mode/time; Output: pulsed, symmetric, biphasic electrical current. Used by patients in home settings for pain relief, muscle performance improvement, and circulation enhancement. Healthcare providers do not operate; device is OTC. Output affects nerve/muscle stimulation; benefits include pain management and muscle conditioning.

Clinical Evidence

Bench testing only. Evaluated for electrical safety (IEC 60601-1, IEC 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993-5, ISO 10993-10), usability (IEC 62366), and software verification/validation per FDA guidance.

Technological Characteristics

ABS plastic housing; DC 3.0V (2x AAA) power; Type BF applied part; 2-channel output; pulsed, symmetric, biphasic waveform; regulated voltage; microprocessor-controlled. Connectivity: wired electrode pads. Sterilization: N/A. Software: firmware-based control.

Indications for Use

Indicated for temporary relief of pain associated with sore/aching muscles in back, neck, upper/lower extremities due to exercise or household strain; symptomatic relief/management of chronic, intractable pain; relief of pain associated with arthritis; stimulation of healthy muscles to improve/facilitate muscle performance; and temporary increase of local blood circulation in healthy muscles.

Regulatory Classification

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.

Predicate Devices

Health Expert Electronic Stimulator, Models: AST-300C and AST-300D (K133929)
Revitive IX (OTC), Model: MT1101 (K143207)
Pain Therapy System, Model: PTS-II (K150277)

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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) #### 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}------------------------------------------------ # 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 OSTO Technology Company Limited | Actegy, Ltd. | Counter Scientific Development (GZ) Ltd. | |--------------------------|---------------------------------------------------------------------------|-------------------------------------|---------------------------------------------| | Device Name and Model | Health Expert Electronic Stimulator, Models: AST- 300C and AST-300D | Revitive IX (OTC), Model: MT1101 | Pain Therapy System, Model: PTS-II | | 510(k) | K133929 | K143207 | K150277 | {4}------------------------------------------------ | 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 | | Regulation Number | 882.5890, 890.5850 | 882.5890, 890.5850 | 882.5890, 890.5850 | | Regulation Class | 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 of Comparison | Subject Device | Predicate Device | Predicate Device | Remark | | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Device Name and Model | Pain Therapy Device, Models: P.T.S-II, P.T.S-IIA, P.T.S-IIB, CP-I | Health Expert Electronic Stimulator Models: AST-300C and AST-300D | Revitive IX (OTC), Model: MT1101 | Pain Therapy System, Model: PTS-II (Primary Predicate) | -- | | 510(k) Number | K163611 | K133929 | K143207 | K150277 | -- | | 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 | PMS (Mode 1~8): It is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. TENS (Mode 9~25): 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. | To temporarily increase local blood circulation in healthy leg muscles. To stimulate healthy muscles in order to improve and facilitate muscle performance. For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties. | To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities (Choose Mode A, B, or C). To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (Arms) due to strain from exercise or normal household work activities (Choose Mode A, B or C). To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (Legs) due to strain from exercise or normal household work activities (Choose Mode A, B or C). To be used for | SE Note 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 of Comparison | Subject Device | Predicate Device | Remark | | | |--------------------------------------------------------------------------------------------------------|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|------------------|--------------| | circulation in healthy muscles (Choose Mode A). | | symptomatic relief and management of chronic, intractable pain and relief of pain associated with Arthritis (Choose Mode A). To stimulate healthy muscles in order to improve and facilitate muscle performance (Choose Mode B). | | | | | OTC or Rx | OTC | OTC | SE | | | | Basic Unit Characteristics | | | | | | | Power Source(s) | DC 3.0V, 2 x AAA | Adaptor Input: 100- 240Vac, 50-60Hz, 0.1A Main Unit Input: 5Vdc, 1A | Adaptor Input: 100- 240Vac, 50/60Hz, 0.18A Main Unit Input: 5.0Vdc, 1.0A | DC 3.0V, 2 x AAA | SE | | Method of Line Current Isolation | Type BF Applied Part | Type BF Applied Part | -- | SE | | | Patient Leakage Current | NC | DC: 0.5 μΑ | AC: 54.5 μΑ, DC: 0.5 μΑ | -- | SE Note 1 | | | SFC | DC: 0.6 μΑ | AC: 120.0 μΑ, DC: 0.6 μΑ | -- | | | Average DC current through electrodes when device is on but no pulses are being applied | | < 0.01 μA | < 0.01 μA | -- | SE | | Number of Output Channels | | 2 Channels: for models P.T.S-II, P.T.S-IIA, P.T.S-IIB; 1 Channel: for model CP-I | 2 | 2 | SE Note 1 | | Number of Output Modes | | 3 | 25 | 1 | SE | | Output Intensity Level | | 5 steps | 99 steps | -- | SE | | Synchronous or Alternating? | | 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 of Comparison | Subject Device | Predicate Device | Predicate Device | Remark | |--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|--------------------------|--------------| | Method of Channel Isolation | Parallel connection | -- | Parallel connection | SE | | Regulated Current or Regulated Voltage? | Regulated Voltage | Regulated Voltage | Regulated Voltage | SE | | Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | SE | | Automatic Overload Trip | No | -- | No | SE | | Automatic No- Load Trip | No | -- | No | SE | | Automatic Shut Off | Yes | -- | Yes | SE | | User Override Control | Yes | -- | Yes | SE | | Indicator Display | On/Off Status | Yes | Yes | SE | | Low Battery | 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: 75g P.T.S-IIA: 100g P.T.S-IIB: 100g CP-I: 66g Electrode: Big Patch Electrode: 40g Small Patch Electrode: 10g Insole Electrode: 200g Sole Plant Electrode A (only for CP-I): 900g Sole Plant Electrode | 2kg (Without accessories) | 1.725kg (Without PSU) | SE Note 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 of Comparison | Subject Device | Predicate Device | | | Remark | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|------------------------------------|----------------------------|--------------| | | B: 920g | | | | | | Dimensions | Main Unit: P.T.S-II: 110 x 78 x 20 mm P.T.S-IIA: 135 x 82 x 20 mm P.T.S-IIB: 135 x 82 x 20 mm CP-I: 92 x 78 x 20 mm Electrode: Large Patch Electrode: 120 x 80 mm Small Patch Electrode: 46 x 46 mm Insole Electrode: 260 x 110 mm Sole Plant Electrode A (only for CP-I): 450 x 450 x 90 mm Sole Plant Electrode B: 450 x 450 x 90 mm | 428mm x 428.8mm x 185mm | Ø360mm x 75mm | 110 x 78 x 20 mm | SE Note 2 | | Housing Materials and Construction | Main unit: ABS plastic | Main unit: ABS plastic | Casing/body: ABS, Footpads: NBR | Main unit: ABS plastic | 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 | | Maximum Output Voltage | 40Vp @ 500Ω | 44V±10% @ 500Ω | -- | 88Vp @ 500Ω | SE | | | 80Vp @ 2kΩ | 80V±10% @ 2kΩ | -- | 102Vp @ 2kΩ | SE Note 3 | | | 95Vp @ 10kΩ | 112V±10% @ 10kΩ | -- | 106Vp @ 10kΩ | | | Maximum Output Current | 80mA @ 500Ω | 88mA±10% @ 500Ω | -- | 176mA @ 500Ω | SE Note 3 | | | 40mA @ 2kΩ | 40mA±10% @ 2kΩ | -- | 51.0mA @ 2kΩ | | | | 9.5mA @ 10kΩ | 11.2mA±10% @10kΩ | -- | 10.6mA @ 10kΩ | | | Pulse Duration | 200µs | 120µs | -- | 170µs | SE Note 3 | {9}------------------------------------------------ | 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 of Comparison | Subject Device | Predicate Device | | Remark | | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------| | Pulse frequency | 13.7~48.5 Hz | 77.3Hz | -- | SE Note 3 | | | Net Charge (per pulse) | 0µC @ 500Ω, Method: Balanced waveform | 0µC @ 500Ω, Method: Balanced waveform | -- | 1.63µC @ 500Ω | SE Note 3 | | Maximum Phase Charge | 19.2µC @ 500Ω | 12.78µC @ 500Ω | -- | 29.9µC @ 500Ω | SE Note 3 | | Maximum Average Current | 1.53mA @ 500Ω | 0.968mA @ 500Ω | -- | 2.22mA | SE Note 3 | | Maximum Current Density (r.m.s) | 0.073mA/cm² @ 500Ω | 0.235mA/cm² @ 500Ω | -- | 8.31mA/cm² @ 500Ω | SE Note 3 | | Maximum Average Power Density | 0.056mW/cm² @ 500Ω | 1.38mW/cm² @ 500Ω | -- | 0.115mW/cm² @ 500Ω | SE Note 3 | | ON Time | 2s | 0.6s | -- | -- | SE Note 3 | | OFF Time | 2s | 0.6s | -- | -- | SE Note 3 | | Additional Features | | | | | | | Operating Environment | Temperature: 5~40°C, Humidity: ≤80%RH, Atmospheric Pressure: 86~106kPa | Temperature: 5~45°C, Humidity: 20~65% RH | -- | -- | SE Note 1 | | Storage Environment | Temperature: Main Unit: -20 ~ 55°C, Electrode Pad: 10 ~ 20°C Humidity: 10~95% RH, Atmospheric Pressure: 50~106 kPa | Temperature: 0~45°C, Humidity: 10~90% RH, Electrode Pad: 10~20°C | -- | -- | SE Note 1 | | Standards | | | | | | | Biocompatibility | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements. | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements. | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements. | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements. | 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 of Comparison | Subject Device | Predicate Device | | Remark | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|--------------------------------------------------|--------| | | Electrode" and "Small Patch Electrode" are cleared in K090198. "Insole Electrode", "Sole Plant Electrode A" and "Sole Plant Electrode B" are cleared in K151693. | | | | | Electrical Safety | Comply with IEC 60601-1 and IEC 60601-2-10 | Comply with IEC 60601-1 and IEC 60601-2-10 | Comply with IEC 60601-1 and IEC 60601-2-10 | SE | | EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | 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 of Comparison | Subject Device (K163611) | Predicate Device (K133929) | Remark | |---------------------------|--------------------------|----------------------------|--------| |---------------------------|--------------------------|----------------------------|--------| {11}------------------------------------------------ | 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 of Comparison | 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 Comparison Group 1 | Mode A | Mode 2 | -- | | - Indications for Use Claim | PMS claims | PMS claims | SE | | - Waveform | Pulsed, Rectangular, Symmetric, Biphasic | Pulsed, Rectangular, Symmetric, Biphasic | SE | | - Pulse Width | 200μs | 120μs | SE Note (a) | | - Pulse Frequency | 48.5Hz | 77.3Hz | SE Note (a) | | - Pulse Cycle Number (T) for One Burst | 200T ~ 206T | 200T | SE Note (a) | | - Maximum Output Voltage | 40Vpk @ 500Ω 80Vpk @ 2kΩ 95Vpk @ 10kΩ | 44Vpk @ 500Ω 80Vpk @ 2kΩ 112Vpk @ 10kΩ | SE Note (b) | | Mode Comparison Group 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 | SE Note (a) | | - Pulse Frequency | 13.7Hz / 19.0Hz | 77.3Hz | SE Note (a) | | - Pulse Cycle Number (T) for One Burst | 82T ~ 113T | 100T | SE Note (a) | | - Maximum Output Voltage | 40Vpk @ 500Ω 80Vpk @ 2kΩ 95Vpk @ 10kΩ | 44Vpk @ 500Ω 80Vpk @ 2kΩ 112Vpk @ 10kΩ | SE Note (b) | | Mode Comparison Group 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 | SE Note (a) | | - Pulse Frequency | 46.1Hz / 38.6Hz / 29.4Hz | 77.3Hz | SE Note (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 of Comparison | Subject Device (K163611) | Predicate Device (K133929) | Remark | |-----------------------------|---------------------------------------------|----------------------------------------------|----------------| | Number (T) for One Burst | | | Note (a) | | - Maximum Output Voltage | 40Vpk @ 500Ω 80Vpk @ 2kΩ 95Vpk @ 10kΩ | 44Vpk @ 500Ω 80Vpk @ 2kΩ 112Vpk @ 10kΩ | SE Note (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

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