ELECTRONIC PULSE MASSAGER

K131933 · Gurin Products, LLC · NUH · Dec 20, 2013 · Neurology

Device Facts

• Record ID: K131933
• Device Name: ELECTRONIC PULSE MASSAGER
• Applicant: Gurin Products, LLC
• Product Code: NUH · Neurology
• Decision Date: Dec 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Santamedical Pulse Stimulator is a portable, microprocessor-controlled Transcutaneous Electrical Nerve Stimulator (TENS) for OTC home use. Device delivers gentle electrical pulses via two channels connected to four attachment pads. User interface includes an LCD display showing mode, intensity, and remaining time. Device features user override controls and automatic shut-off. Intended to provide temporary pain relief for sore/aching muscles resulting from exercise or daily activities. Healthcare providers do not operate the device; it is intended for patient self-administration. Output parameters (frequency 1-100 Hz, monophasic pulsed waveform) are managed by the internal microprocessor to ensure consistent stimulation delivery.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, including electrical safety and electromagnetic compatibility testing per IEC 60601-1 and IEC 60601-1-2, and software verification conducted in accordance with FDA guidance.

Technological Characteristics

Portable TENS device; ABS plastic housing; battery-powered; 2 output channels; 4 attachment pads. Waveform: monophasic, pulsed. Frequency: 1-100 Hz. Features: LCD display, automatic shut-off, user override. Standards: IEC 60601-1, IEC 60601-1-2, 21 CFR 898. Software verification performed per FDA guidance.

Indications for Use

Indicated for temporary relief of muscle pain in shoulder, waist, back, neck, arms, and legs caused by exercise or household/work strain. For over-the-counter, home 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

• Prospera OTC TENS Electronic Pulse Massager (K122744)

Submission Summary (Full Text)

{0}------------------------------------------------

#### K131933

#### Exhibit 013 Revised 510(k) Summary

This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

#### 1. Submitter's Information

Submitter: Gurin Products, LLC Address: 2522 Chambers Road, Suite 100, Tustin, CA 92780 Contact Person: Sanjay Gupta Tel: [phone] Email: [e-mail] Date of Preparation: 06/24/2013

#### 2. Proposed Device

Trade Name: Santamedical Pulse Stimulator Common Name: Transcutaneous electrical nerve stimulator Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter (OTC) Regulation Description: Transcutaneous electrical nerve stimulator for pain relief Regulation Medical Specialty: Neurology Review Panel: Neurology Product Code: NUH, NGX Regulation Number: 21 CFR 882.5890 Use: Over-The-Counter Device Class: II

#### 3. Predicate device

Prospera OTC TENS Electronic Pulse Massager 510(k) Number: K122744 Submitter: Prospera Corporation

#### 4. Description of Proposed Device

The Santamedical Pulse Stimulator, a Transcutaneous Electrical Nerve Stimulator (TENS), is for overthe-counter use and for home use, which is intended to relieve pain associated with sore and aching muscles in the shoulder, waist, neck, back, arm, and leg, due to strain from exercise or normal household and work activities. The portable and microprocessor-controlled Santamedical Pulse Stimulator delivers a gentle electrical pulse through two channels with four attachment pads and shows graphic information about mode style, intensity and time remaining on a LCD based display which is incorporated within the device body.

#### 5. Indications for Use

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.

#### 6. Technological Characteristics

Both the proposed and predicate devices have the identical technological characteristics, as shown in Table 1 below.

{1}------------------------------------------------

| | Proposed Device | Predicate Device |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K131933 | K122744 |
| Device Name | Santamedical Pulse Stimulator | Prospera OTC TENS Electronic<br>Pulse Massager |
| Intended Use | To be used for temporary relief<br>of pain associated with sore<br>and aching muscles in the<br>shoulder, waist, back, neck,<br>upper extremities (arm), and<br>lower extremities (leg) due to<br>strain from exercise or normal<br>household work activities. | To be used for temporary relief<br>of pain associated with sore and<br>aching muscles in the shoulder,<br>waist, back, neck, upper<br>extremities (arm), and lower<br>extremities (leg) due to strain<br>from exercise or normal<br>household work activities. |
| Power Source | Battery | Battery |
| Number of Output Channels | 2 | 2 |
| Automatic Overload Trip | No | No |
| Automatic Over Current Trip | No | No |
| Automatic No-Load Trip | No | No |
| Automatic Shut Off | Yes | Yes |
| User Override Control | Yes | Yes |
| Indicator Display | Yes | Yes |
| Waveform | Monophasic, pulsed | Monophasic, pulsed |
| Frequency | 1-100 Hz | 1-100 Hz |
| Compliance with Voluntary<br>Standards | IEC60601-1, IEC60601-1-2 | IEC60601-1, IEC60601-1-2 |
| Compliance with 21 CFR 898 | Yes | Yes |
| Housing Materials &<br>Construction | ABS Plastic | ABS Plastic |

Tablo 1 Charactoristic com parison hetween the proposed device and predicate device

#### 7. Non-Clinical Tests Performed for Determination of Substantial Equivalence

Compliance to applicable voluntary standards includes IEC 60601-1-2. Non-clinical tests were performed on the proposed Santamedical Pulse Stimulator in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, electromagnetic compatibility, and particular requirements for the safety of nerve and muscle stimulators:

- (a) IEC 60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance".
- (b) IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Safety -Collateral standard: Electromagnetic Compatibility - Requirements and Tests".

In addition to the compliance of voluntary standards, the electrodes also meet the safety requirement, and the software verification has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

#### 8. Conclusion

The proposed device is substantially equivalent to the predicate device. Therefore, the proposed Santamedical Pulse Stimulator is as safe, as effective, and performs as well as the foregoing identified OTC predicate devices which have been legally marketed in the United States.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 20, 2013

Gurin Products, LLC Sanjay Gupta President 2522 Chambers Road, Suite 100 Tustin, CA 92780

Re: K131933

Trade/Device Name: Santamedical Pulse Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: November 25, 2013 Received: December 3, 2013

Dear Mr. Gupta:

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.

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

{3}------------------------------------------------

Page 2 - Mr. Sanjay Gupta

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,

## Joyce M. Whang -S

for

Carlos L. Peña, PhD Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

### Indications for Use

510(k) Number (if known): K131933

Device Name: Santamedical Pulse Stimulator

Indications For Use:

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.

Prescription Use (Part 21 CFR 801 Subpart D)

and the same of the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of

AND/OR

Over-The-Counter Use _ X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

# Joyce M. Whang -S

Page 1 of __ 1__