(252 days)
Not Found
No
The summary describes a standard TENS/PMS device with pre-programmed modes and does not mention any AI/ML capabilities or related performance metrics.
Yes
The device is described as both a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief and a Powered Muscle Stimulator (PMS) for improving muscle performance, both of which are therapeutic applications.
No
The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS), intended for temporary pain relief and muscle performance improvement. Its functions are therapeutic (stimulation for pain relief and muscle performance), not diagnostic (identifying or characterizing a disease or condition).
No
The device description explicitly states it is a "portable; battery powered (3.7VDC) multi-function device" with "Two channels effectively transfer your desired choice of programmed electrical pulses directly through electrode adhesive pads," indicating it is a hardware device that delivers electrical stimulation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a TENS and PMS device for pain relief and muscle stimulation. These are therapeutic applications, not diagnostic tests performed on samples taken from the human body.
- Device Description: The description details a portable, battery-powered device that delivers electrical pulses through electrodes placed on the body. This aligns with the function of a TENS/PMS device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
- Anatomical Site: The anatomical sites listed are areas on the external body where electrodes are placed, not locations from which samples are collected for analysis.
In summary, the device's function and intended use are entirely focused on delivering electrical stimulation to the body for therapeutic purposes, which is the definition of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
TENS: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS: It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Product codes
NUH, NGX
Device Description
The BH - 18 is a portable; battery powered (3.7VDC) multi-function device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities in one device.
Two channels effectively transfer your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, there are 6 modes of operation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg)
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
Non-clinical testing performed includes compliance to applicable voluntary standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11 and ISO 14971. In addition, software verification has been carried out according to the FDA guidance for the content of premarket submissions for software contained in medical devices. The safety of the device for proposed indications without medical prescriptions or supervision is established by the fact that no adverse events have been reported for units sold without a prescription in Europe and Asia. The effectiveness of the device is supported by articles in peer-reviewed publications demonstrating that electrical stimulation improves muscle performance and reduces pain.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K132563
APR 2 4 2014
Summary Traditional 510(K)
SUBMITTER INFORMATION
| Submitter's Name: | Pinook USA |
|---|---|
| Submitter's Address: | 901 Central Florida Pkw |
| Suite A6 | |
| Orlando, Florida 32824 | |
| Contact Person: | Mr. Dvir Lev-Ran |
| Email: | dvirkush@yahoo.com |
| dvir@pinookusa.com | |
| Phone: | 855.606.4303 |
| Fax: | 888.505.0681 |
| Date of Summary Submission: | July 29, 2013 |
| Resubmitting on: | March 24th, 2014 |
| 510(K) Number: | K132563 |
NEW DEVICE FOR WHICH SUBMITTING:
| Device Trade Name: | Pinook Stimulator |
|---|---|
| Model: | BH-18 |
| Device Common Name: | Transcutaneous Electrical Nerve Stimulator and Powered |
| Muscle Stimulator | |
| Classification Name: | Stimulator, Nerve, Transcutaneous, Over-the-Counter |
| Stimulator, Muscle, Powered, For Muscle Conditioning | |
| Device's Classification Panel: | Neurology |
| Physical Medicine | |
| Regulatory Class: | Class II |
| Product Code: | |
| Regulation Number: | NUH, NGX |
| 882.5890 |
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MANUFACTURER INFORMATION:
| Name: | JOHARI DIGITAL HEALTHCARE LTD. | ||
|---|---|---|---|
| Address and Registration: | G-582 - 583, EPIP, Boranada, Jodhpur 342008 | ||
| FDA Registration: | 8040537 | ||
| Predicate Device: | |||
| Device Trade Name: | Hi-Dow | ||
| Model: | JQ-5C | ||
| Classification Name: | Stimulator, Nerve, Transcutaneous, Over-the-Counter | ||
| Stimulator, Muscle, Powered, For Muscle Conditioning | |||
| 510(K) Number: | K102598 | ||
| Device's Classification Panel: | Neurology (As Per 21 CFR Section 882.5890) | ||
| Physical Medicine (As Per 21 CFR Sections 890.5850) | |||
| Regulatory Class: | Class II | ||
| Product Code: | NUH, NGX | ||
| Regulation Number: | 882.5890 | ||
| Manufacturer: | Hi-Dow International, Inc | ||
| Address: | 2071 Congressional Drive, Saint Louis, MO 61346 |
DESCRIPTION OF THE NEW DEVICE
BH - 18:
The BH - 18 is a portable; battery powered (3.7VDC) multi-function device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities in one device.
Two channels effectively transfer your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, there are 6 modes of operation.
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INTENDED USE OF DEVICE
TENS:
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS:
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
SUMMARY OF SUBSTANTIAL EQUIVALENCE
Comparison of BH - 18 and the predicate JQ-5C.
| S.No | Description | Pinook Stimulator | Hi-Dow |
|---|---|---|---|
| 1. | Max Output Voltage over 10k, V | 84 V @ 10KΩ | |
| 79 V @ 2.2KΩ | |||
| 61 V @ 500Ω | 84 V @ 10KΩ | ||
| 79.2 V @ 2.2KΩ | |||
| 62.4 V @ 500Ω | |||
| 2. | Max- Current over 10k, mA | 8.4 mA @ 10KΩ | |
| 39.5 mA @ 2.2KΩ | |||
| 122 mA @ 500Ω | 8.4 mA @ 10KΩ | ||
| 39.6 mA @ 2.2KΩ | |||
| 124.8 mA @ 500Ω | |||
| 3. | Pulse Width, micro seconds | 100 | 100 |
| 4. | Pulse Period, msec | 16.3-833Ms | 16.3-833mS |
| 5. | Max. Pulse Frequency, Hz | 62 | 61.3 |
| 6. | Net Charge µC per pulse | 0 | 0 |
| 7. | Max Phase Charge over 500Ω, µC | 12.2 | 12.48 |
| 8. | Max Current Density over 500Ω, mA/cm2 | 11.77 | 12.04 |
| 9. | Max Power Density over 500 Ω, W/cm² | 0.718 W/cm² | 0.747 W/cm² |
| 10. | For multiphasic waveforms only: | ||
| -Symmetrical phases? |
- Phase Duration† (include units) | YES
100μS | YES
100μS |
| 11. | ON Time (seconds) | 5 Seconds (M2, M3 & M4) | 5 Seconds (M2, M3 & M4) |
| 12. | OFF Time (seconds) | 3 Sec. (M2),
2 Sec. (M3 & M4) | 3 Sec. (M2),
2 Sec. (M3 & M4) |
SUBSTANTIAL EQUIVALENCE
The electrical stimulation provided by the BH-18 is substantially equivalent to that commonly employed by muscle stimulators and TENS devices that have been cleared for
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marketing without prescription labelling: i.e. for OTC sale. The pulses in the waveform combinations are restricted in amplitude and duration and is consistent with the other device quoted above.
The differences that exist between the devices are insignificant in the terms of safety or effectiveness.
The BH -18 has modes that offer substantially equivalent technical specifications. features and effective results as the predicate listed.
NON-CLINICAL TESTING PERFORMED
Compliance to applicable voluntary standards includes IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10,IEC 60601-1-11 and ISO 14971.
In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA guidance for the content of premarket submissions for software contained in medical devices.
CONCLUSION
The electrical stimulation provided by the BH-18 is similar to the commonly employed muscle stimulators and TENS devices that have been cleared for marketing without prescription labelling.
The BH-18 has the same intended uses and the similar technological characteristics as its OTC predicate. Moreover, verification and validation tests contained in this submission demonstrate that the differences in BH-18 still maintain the same safety and effectiveness as that of the cleared device.
In other words, the engineering differences do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.
Concerns of safe and proper use of electrodes and electrode pad placement have been fully addressed by making the user conscious of the proper placement of the electrodes and proper operations of the device through detail in the User's Instruction Manual.
There are no new safety or effectiveness issues concerning the new device.
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The safety of the device, to be used for the proposed indications without medical prescriptions or supervision, is established by the fact that no adverse events have been reported for units sold without a prescription in Europe and Asia. This also proves that its specific technical, safety measures and features are safe and effective when used without medical supervision.
The effectiveness of the device for the proposed indications is supported by a number of articles in peer-reviewed publications, which demonstrates that electrical stimulation does improve muscle performance as well as pain reduction.
Technological characteristics, features, specifications, materials and intended uses of the BH-18 are substantially equivalent to the quoted predicate device.
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 24, 2014
Pinook USA, LLC c/o Dvir Lev-Ran 901 Central Florida Parkway, Suite A6 Orlando, FL 32824
Re: K132563
Trade/Device Name: Pinook Stimulator, Model BH-18 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX Dated: March 24, 2014 Received: March 27, 2014
Dear Mr. Lev-Ran:
We have reviewed vour 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.
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
6
Page 2 - Mr. Dvir Lev-Ran
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Carlos L. Pena -S
Carlos L. Peña. Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132563
Device Name
Pinook Stimulator, Model BH-18
Indications for Use (Describe)
TENS: To be used for temporary relief of pain associated with sore and acting muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities
PMS: To be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Type of Use (Select one or both, as applicable)
[ ] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY 1 31, 97 : , "+ . :-.
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Carlos EBena -S
- . …
. :
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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