PINOOK STIMULATOR

K132563 · Pinook USA · NUH · Apr 24, 2014 · Neurology

Device Facts

• Record ID: K132563
• Device Name: PINOOK STIMULATOR
• Applicant: Pinook USA
• Product Code: NUH · Neurology
• Decision Date: Apr 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Pinook Stimulator (BH-18) is a portable, battery-powered (3.7VDC) device combining TENS and Powered Muscle Stimulator (PMS) functions. Device delivers programmed electrical pulses via two channels through adhesive electrode pads placed on the body. Features 6 operation modes. Used by patients in home settings without medical supervision. Output parameters (voltage, current, frequency, pulse width) are controlled to ensure safety for OTC use. Healthcare providers or patients use the device to manage muscle pain or enhance muscle performance. Benefits include non-pharmacological pain relief and muscle conditioning.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, compliance with voluntary safety standards (IEC 60601-1, 60601-1-2, 60601-2-10, 60601-1-11, ISO 14971), and software verification. Effectiveness is supported by literature references regarding electrical stimulation for pain reduction and muscle performance.

Technological Characteristics

Portable, battery-powered (3.7VDC) TENS/PMS device. Two-channel output. Waveforms: multiphasic, symmetrical phases. Pulse width: 100µs; Pulse period: 16.3-833ms; Max frequency: 62Hz. Connectivity: None. Sterilization: N/A. Software: Embedded firmware for pulse generation and mode control.

Indications for Use

Indicated for individuals seeking temporary relief of muscle pain (shoulder, waist, back, neck, arms, legs) due to exercise or household strain, and for stimulation of healthy muscles to improve/facilitate muscle performance. OTC use.

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

• Hi-Dow (K102598)

Submission Summary (Full Text)

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# K132563

# APR 2 4 2014

# Summary Traditional 510(K)

# SUBMITTER INFORMATION

| Submitter's Name: | Pinook USA |
|-----------------------------|---------------------------------------------------------------|
| Submitter's Address: | 901 Central Florida Pkw<br>Suite A6<br>Orlando, Florida 32824 |
| Contact Person: | Mr. Dvir Lev-Ran |
| Email: | [e-mail]<br>[e-mail] |
| 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<br>Muscle Stimulator |
| Classification Name: | Stimulator, Nerve, Transcutaneous, Over-the-Counter<br>Stimulator, Muscle, Powered, For Muscle Conditioning |
| Device's Classification Panel: | Neurology<br>Physical Medicine |
| Regulatory Class: | Class II |
| Product Code:<br>Regulation Number: | NUH, NGX<br>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<br>Stimulator, Muscle, Powered, For Muscle Conditioning | | |
| 510(K) Number: | K102598 | | |
| Device's Classification Panel: | Neurology (As Per 21 CFR Section 882.5890)<br>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<br>79 V @ 2.2KΩ<br>61 V @ 500Ω | 84 V @ 10KΩ<br>79.2 V @ 2.2KΩ<br>62.4 V @ 500Ω |
| 2. | Max- Current over 10k, mA | 8.4 mA @ 10KΩ<br>39.5 mA @ 2.2KΩ<br>122 mA @ 500Ω | 8.4 mA @ 10KΩ<br>39.6 mA @ 2.2KΩ<br>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:<br>-Symmetrical phases?<br>- Phase Duration† (include units) | YES<br>100μS | YES<br>100μS |
| 11. | ON Time (seconds) | 5 Seconds (M2, M3 & M4) | 5 Seconds (M2, M3 & M4) |
| 12. | OFF Time (seconds) | 3 Sec. (M2),<br>2 Sec. (M3 & M4) | 3 Sec. (M2),<br>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

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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 [phone] or [phone] 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 [phone] or [phone] 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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