(263 days)
No
The summary does not mention AI, ML, or any related terms, and the device description is consistent with a standard electrical stimulator.
Yes
The device is used for the symptomatic relief and management of chronic pain, which is a therapeutic purpose.
No
The device is described as a "Pain Relief System" and a "hand-held stimulator designed to pass electrical signals via surface electrodes through the skin to the underlying nerves" for "symptomatic relief and management of chronic intractable pain." It is not described as identifying or classifying a disease or condition.
No
The device description explicitly states it is a "hand-held stimulator designed to pass electrical signals via surface electrodes through the skin," indicating it is a hardware device that delivers electrical stimulation.
Based on the provided information, the StimOn™ Pain Relief System (GM2439) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical or post-traumatic pain. This involves applying electrical signals to the body for therapeutic purposes.
- Device Description: The device is described as a hand-held stimulator that passes electrical signals via surface electrodes through the skin to underlying nerves. This is a physical intervention, not a diagnostic test performed on samples taken from the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The StimOn™ system does not perform any such analysis on biological samples.
Therefore, the StimOn™ Pain Relief System is a therapeutic device, specifically a TENS (Transcutaneous Electrical Nerve Stimulation) device, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
StimOn™ Pain Relief System (GM2439) is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical or post-traumatic pain.
Product codes (comma separated list FDA assigned to the subject device)
GZJ
Device Description
StimOn™ Pain Relief System (GM2439) is a hand-held stimulator designed to pass electrical signals via surface electrodes through the skin to the underlying nerves. It may be used as a TENS device to aid the blocking of pain signals traveling to the brain.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intended use. The following tests were performed on the device:
- IEC 60601-1. Medical Electrical Equipment Part 1: General Requirements for Safety,
- IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- IEC 60601-1-11: Medical Electrical Equipment Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-2-10: Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- ASI/AAMI NS4: Medical Electrical Equipment Transcutaneous electrical nerve stimulators
Biocompatibility and Performance of electrodes: The subject device utilizes electrodes cleared under K180865. Performance data (e.g. impedance, current dispersion, adhesion and electrode stability) and biocompatibility testing for the electrodes was leveraged from K180865.
Animal testing: No animal studies have been required for these devices.
Clinical testing: No Human Clinical Performance Testing have been required for StimOn™ Pain Relief System (GM2439) device for this application.
Usability: The StimOn™ Pain Relief System (GM2439) is similar in intended use and technical specifications to the BioWaveGO (K180943), which was cleared for over-the-counter (OTC) use. The subject device also complies with IEC 62366: Medical devices Part 1: Application of usability engineering to medical devices.
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/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
August 26, 2022
Gimer Medical Co., Ltd. % Anita Chen RA ZhengCheng Limited Company 238 No.19. 335 Lane, Fu-Xi Road, Shulin District New Taipei City, Taiwan 238 Taiwan
Re: K213802
Trade/Device Name: StimOn™ Pain Relief System (GM2439) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: July 5, 2022 Received: July 25, 2022
Dear Anita Chen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213802
Device Name StimOn™ Pain Relief System (GM2439)
Indications for Use (Describe)
StimOn™ Pain Relief System (GM2439) is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical or post-traumatic pain.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This 510(k) summary of safety and effectiveness information is submitted as part of the Premarket Notification in compliance with requirements of CFR Part 807, Subpart E and Section 807.92.
The assigned 510(k) Number: K213802
| 1. | Manufacturer | Gimer Medical Co., Ltd. |
|---|---|---|
| Mail Address | Address: 9F.-5, No. 97, Sec. 1, Xintai 5th Road, | |
| Xizhi District, New Taipei City, Taiwan | ||
| Tel. +886-2-2697-2680 | ||
| Fax. +886-2-2697-2670 | ||
| Website: http://www.gimermed.com/ | ||
| Manufacturer address | Address: 9F.-7 and 9F.-8, No. 97, Sec. 1, Xintai 5th | |
| Road, Xizhi District, New Taipei City, Taiwan | ||
| Contact Person | Mrs. Anita Chen/ Regulatory Advisor of Gimer | |
| Medical Co., Ltd. | ||
| Phone: | +886(0) 939-855-759 | |
| E-mail: | Anita9104303@gmail.com | |
| Date Prepared | 8/26/22 | |
| 2 | Device Name | |
| Trade Name: | StimOn™ Pain Relief System (GM2439) | |
| Common or usual name | Nerve stimulator | |
| Product Code | GZJ | |
| Regulation Name | Transcutaneous electrical nerve stimulator for pain | |
| relief | ||
| CFR Classification | CFR Part 882.5890 | |
| Device Class | II | |
| Classification Panel | Neurology | |
| 3 | Primary Predicate Device | |
| 510(k) number: | K081835 | |
| Trade or proprietary or | Bioinduction Acticare HFT/HFI |
4
model name:
4
| Manufacturer: | Bioinduction Limited
(178-180 Hotwell Road, BRISTOL, BS8 4RP,
United Kingdom, Telephone number: +44 117 37
5275, Fax number: +44 117 377 5405) |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Secondary Predicate Device | |
| 510(k) number: | K161091 |
| Trade or proprietary or
model name: | STIMPOD NMS460 Nerve Stimulator |
| Manufacturer: | XAVANT TECHNOLOGY (PTY) LTD
Street Address: Unit 102 The Tannery Industrial
Park
309 Derdepoort Road
Silverton
City: Pretoria
State/Province: Gauteng
Country: South Africa |
| Reference Device of
Electrode Pad (Accessary) | |
| 510(k) number: | K180865 |
| Trade or proprietary or model
name: | ZMI Self-Adhesive Electrodes |
| Manufacturer: | ZMI Electronics, Ltd.
6F-1,286-4,Shin Ya Road
Kaohsiung, TW 806 |
| Reference Device for OTC
usability | |
| 510(k) number: | K180943 |
| Trade or proprietary or model
name: | BioWaveGO |
| Manufacturer: | Biowave Corporation
8 Knight Street, Suite 201
Norwalk, CT 06851 |
5
| 5 | Device Description: | StimOn™ Pain Relief System (GM2439) is a hand-held stimulator designed to pass electrical signals via surface electrodes through the skin to the underlying nerves. It may be used as a TENS device to aid the blocking of pain signals traveling to the brain. |
|---|---|---|
| --- | --------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
6
-
- Indications for Use: StimOn™ Pain Relief System (GM2439) is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical or post-traumatic pain. 7. Technological A comparison of the device features, intended use, and
- Characteristics and Substantial Equivalence Comparison with Predicates:
other information demonstrates that the Product name is substantially equivalent to the predicate device as summarized in Table 1. The differences raise no new question of safety and effectiveness.
Table 1. Comparison table
| Description | Subject Device | Predicate Device | Predicate Device |
|---|---|---|---|
| 510(k) Number | K213802 | K081835 | K161091 |
| Manufacture | Gimer Medical | ||
| Co., Ltd | Bioinduction Limited | XAVANT | |
| TECHNOLOGY | |||
| (PTY) LTD | |||
| Product code | GZJ | GZJ, IPF | GZJ |
| Device Name | StimOn™ | ||
| Pain Relief System | |||
| (GM2439) | BioinductionActicare | ||
| HFT/HFI | STIMPOD | ||
| NMS460Nerve | |||
| Stimulator | |||
| Indications for use | StimOn™ Pain | ||
| Relief System | |||
| (GM2439) is used | |||
| for the symptomatic | |||
| relief and | |||
| management of | |||
| chronic intractable | |||
| pain and/or as an | |||
| adjunctive treatment | |||
| in the management | |||
| of post-surgical or | As a Transcutaneous | ||
| Electronic Nerve | |||
| Stimulation (TENS) | |||
| device for: the | |||
| symptomatic relief of | |||
| chronic intractable | |||
| pain, and as an | |||
| adjunctive treatment | The STIMPOD | ||
| NMS460 Nerve | |||
| Stimulator is a | |||
| Transcutaneous | |||
| Electrical Nerve | |||
| Stimulation(TENS) | |||
| device used for | |||
| symptomatic relief | |||
| post-traumatic pain | in the management of | and management of | |
| post-surgical or | chronic intractable | ||
| post-traumatic pain. | pain and/or as an | ||
| As a Neuromuscular | adjunctive | ||
| Electrostimulation | treatment in the | ||
| (NMS) device for: | management of | ||
| the relaxation of | post-surgical pain, | ||
| muscle | post traumatic acute | ||
| spasms, prevention or | pain problems, as | ||
| retardation of disuse | well as an adjunct | ||
| atrophy, increasing | |||
| local blood | for pain control due | ||
| to rehabilitation. | |||
| circulation, muscle | |||
| re-education, | |||
| immediate post- | |||
| surgical stimulation | |||
| of the calf muscles to | |||
| prevent venous | |||
| thrombosis and to | |||
| maintain or increase | |||
| the range of motion. | |||
| Prescription/over- | |||
| the counter use | Over-the-counter | ||
| use | Prescription | Prescription | |
| Power Supply | One 3.7V, 125mAh | ||
| rechargeable | |||
| Lithium polymer | |||
| battery | Not publicly | ||
| available | 4 x AAA alkaline | ||
| batteries | |||
| Treatment Timer | |||
| Maximum | 15 minutes | Not publicly | |
| available | 99 minutes |
7
8
| Number of Output
| Modes | 1 (RF Mode) | Not publicly available | 1 |
|---|---|---|---|
| Number of | |||
| Waveforms | 1 | Not publicly available | 2 (Monophasic, |
| Biphasic with offset) | |||
| Waveform | Biphasic(Sine | ||
| Wave) | Not publicly available | Monophasic square | |
| wave/Hybrid RF | |||
| wave | |||
| RF | |||
| Stimulation | |||
| Mode | Transcutaneous | ||
| Pulsed Radio- | |||
| frequency(PRF) | |||
| mode | Not publicly available | Hybrid RF | |
| waveform which | |||
| consists of a | |||
| Monophasic Square | |||
| Wave with a | |||
| superimposed Radio | |||
| Frequency waveform | |||
| RF Frequency | 500 kHz fixed | Not publicly available | 160kHz fixed |
| Burst Time | 25ms | Not publicly available | 100μs, 200μs |
| Burst Frequency | 2Hz | Not publicly available | 1,2,5,10 Hz |
| Electrode Contact | Hydrogel pad | Not publicly available | Probe electrode |
| Load Impedance | 1 k Ohm, Over this | ||
| load, the system | |||
| will automatically | |||
| shut off. | Not publicly available | 7 K Ohm |
9
| Maximum Output
Voltage | 7.4 V+/-10%
6.6 V +/- 20% @
@500Ω with
Electrode Pad | Not publicly
available | 220 V |
|----------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------|------------------------|
| Maximum Output
Current | 14.8 mA
(Peak)@500Ω
13.2 mA
(Peak)@500Ω with
Electrode Pad | Not publicly
available | 43.7mA @500Ohm |
| Maximum
Average Current
(Over primary
phase) | 9.43 mA (Peak)
@500Ω
8.41mA(Peak)
@500Ω with
Electrode | Not publicly
available | 29.85mA@500Ohm |
| Maximum
Average Power
Density (Smallest
electrode area) “P” | 112.81 µW/mm²
@500Ohm with
Electrode | Notpublicly
available | 71.5µW/mm²
@500Ohm |
| Maximum
Current (RMS)
Density
(mA/mm²) | 0.0242 mA /mm²
@500Ω
with Electrode | Not publicly
available | 93.28µA/mm²
@500Ohm |
| Net Charge | The theoretical value
is 0. | Not publicly
available | 6.06μC |
| Maximum
averagephase
charge [µC] | 0.00942μC | Notpublicly
available | 6.06µC |
10
Summary of the technological characteristics of subject and predicate devices:
The StimOn™ Pain Relief System (GM2439) and Bioinduction Acticare are the same in use for body contact with the hydrogel pad. The other predicate STMPOD NMS460 is using the probe electrode instead. The subject and predicate devices have available RF stimulation modes. The slight differences between these three devices are the burst time. burst frequency, and RF frequency and the differences between the three devices are treatment timer maximum, power source, load impedance and maximum output.
The StimOn™ Pain Relief System (G2439) only has a single stimulation treatment mode at 500KHz, and impedance ranges from 100 to 1000 ohms to simplify the operation of device. Comparison of RF Stimulating Options (RF mode) of StimOn™ Pain Relief System (GM2439), and two predicates of Bioinduction Acticare and STMPOD NMS460 in waveform, RF Frequency, Burst time, Burst Frequency in Table1.
It indicated that from a safety perspective, the StimOn™ Pain Relief System (GM2439) its maximum average power density is within the value range of the two predicates (above STIMPOD and below Acticare). Thus, in the RF mode of energy output mechanism, it could infer that the treatment efficacy of StimOn™ Pain Relief System (GM2439) is sufficient to compare with the two predicate device and the differences between the subject and predicate(s) do not impact safety and effectiveness.
8. Performance Testing
Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intended use. The following tests were performed on the device.
- IEC 60601-1. Medical Electrical Equipment Part 1: General Requirements for Safety,
- •IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- •IEC 60601-1-11: Medical Electrical Equipment Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- · IEC 60601-2-10: Medical electrical equipment Part 2: Particular requirements for the
11
basic safety and essential performance of nerve and muscle stimulators
· ASI/AAMI NS4: Medical Electrical Equipment Transcutaneous electrical nerve stimulators
Biocompatibility and Performance of electrodes:
The subject device utilizes electrodes cleared under K180865. Performance data (e.g. impedance, current dispersion, adhesion and electrode stability) and biocompatibility testing for the electrodes was leveraged from K180865.
Animal testing
No animal studies have been required for these devices.
Clinical testing
No Human Clinical Performance Testing have been required for StimOn™ Pain Relief System (GM2439) device for this application.
Usabilitv
The StimOn™ Pain Relief System (GM2439) is similar in intended use and technical specifications to the BioWaveGO (K180943), which was cleared for over-the-counter (OTC) use. The subject device also complies with IEC 62366: Medical devices Part 1: Application of usability engineering to medical devices.
9. Conclusion
StimOn™ Pain Relief System (GM2439) has the same intended use as the predicate device. Although there is a slightly different technological design, as compared to the predicate, the conclusions drawn from the test data demonstrate that the device is as safe and as effective as the legally marketed device identified in the submission. Therefore, the subject device is "Substantially Equivalent" to the predicate devices.