(271 days)
No
The summary describes a basic electrical stimulator with pre-set modes and manual controls, with no mention of adaptive algorithms, learning capabilities, or AI/ML terminology.
Yes
The device is described as a "Pain Therapy Device" with indications for temporary pain relief, symptomatic relief and management of chronic pain, improvement of muscle performance, and temporary increase of local blood circulation, all of which are therapeutic applications.
No.
The device's intended use and description clearly state its purpose is for temporary pain relief, muscle stimulation, and increasing local blood circulation, which are therapeutic functions, not diagnostic ones. It does not mention any ability to detect, identify, or monitor medical conditions or diseases.
No
The device description explicitly mentions a "main unit" with operating elements, electrode pads, and electrode wires, indicating physical hardware components are integral to its function. The software verification and validation test is listed as one of several tests, implying the software is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device applies electrical current to stimulate nerves and muscles for pain relief and muscle performance improvement. It interacts directly with the body's surface.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens.
The device is a therapeutic electrical stimulator, not a diagnostic tool that analyzes samples.
N/A
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).
Product codes (comma separated list FDA assigned to the subject device)
NUH, NYN, NGX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
household
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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)
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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 |