PAIN-AID

K113037 · Pdi Works, LLC · NUH · Mar 1, 2012 · Neurology

Device Facts

• Record ID: K113037
• Device Name: PAIN-AID
• Applicant: Pdi Works, LLC
• Product Code: NUH · Neurology
• Decision Date: Mar 1, 2012
• 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 upper and lower back, and upper and lower extremities due to strain from exercise or normal household and work activities. To be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

Device Story

Pain-Aid is a transcutaneous electrical nerve stimulator (TENS) for OTC muscular pain relief. Device consists of a microprocessor-controlled unit powered by a coin cell, housed in a small plastic case. User interface features three buttons: power, intensity increase, and intensity decrease; buttons have distinctive shapes for tactile identification. Device connects directly to self-adhesive electrodes via snaps, eliminating leadwires. Electrodes are shaped to facilitate proper body placement. User applies electrodes to skin; device delivers asymmetrical biphasic electrical stimulation to nerves. Output intensity is adjusted by the user to manage pain. Intended for home use by untrained individuals to provide temporary relief from muscle strain, chronic pain, and arthritis.

Clinical Evidence

Bench testing only. Comparison of electrical output waveforms and parameters against predicate devices demonstrated substantial equivalence.

Technological Characteristics

Microprocessor-controlled TENS device; battery-powered (coin cell). Output: Asymmetrical biphasic waveform. Patient interface: Self-adhesive electrodes with snap-on connection (no leadwires). Form factor: Small plastic case with three-button tactile interface. Regulatory class: II.

Indications for Use

Indicated for temporary relief of sore/aching muscles in upper/lower back and extremities due to exercise or daily activities; also for symptomatic relief/management of chronic, intractable pain and arthritis-associated pain. For 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

• Endurance Therapeutics Therapeutic Massage Companion (K060846)
• Empi Select (K061650)

Submission Summary (Full Text)

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## MAR - 1 2012

510 k): k113032

## 510(k) Summary

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

1. Submitters Information:

Thu-Ha Duncan PDI Works, LLC 2150 South Lee Highway Cleveland, TN 37311 423-303-9981 [e-mail] Prepared June 1, 2011

2. Device Identification:

Classification Name: Transcutaneous Nerve Stimulator. Trade/Proprietary Name: Pain-Aid Classification: Class II (21 CFR 882.5890) Product Code: NUH, NYN

3. Identification of Predicate Devices:

The PDI Works Pain-Aid is of comparable type and substantially equivalent to the following predicate devices:

Endurance Therapeutics Therapeutic Massage Companion, K060846 Empi Select, K061650

4. Device Description:

The Pain-Aid is a transcutaneous electrical nerve stimulator for relief of muscular pain and sold without prescription. Key to its use are specially shaped electrodes that allow an untrained person to properly place them on the body.

The device consists of a microprocessor and associated components powered by a coin cell and housed in a small plastic case.

The controls for the device consist of three buttons: A power button which turns the device on and off, an intensity increase button, and an intensity decrease button. This simple user interface is further augmented by distinctive shapes to allow the user to identify the controls even if they cannot see the device.

Contact to the body is made through self-adhesive electrodes. Electrical connection from the device to the electrode is made directly through snaps on the device and the electrode; no leadwires are used. The electrodes are designed with both conductive surfaces combined into a single .

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These electrodes are manufactured in various shapes to facilitate proper placement on the body.

### 5. Intended Use:

To be used for temporary relief of pain associated with sore and aching muscles in the upper and To be used for temporary relever extremities due to strain from exercise or normal household and work activities. It is also intended to relieve chronic pain and pain due to arthritis.

## 6. Technological Characteristics

devices:

| | Pain-Aid | Therapeutic Massage<br>Companion | Empi Select |
|--------------------------------|-----------------------------------------------|-----------------------------------------------|---------------------------------------------------------------|
| Intended Use | Muscular Pain Relief | Muscular Pain Relief | Muscular Pain Relief,<br>Chronic and Arthritis<br>Pain Relief |
| Output Waveform | Asymmetrical<br>Biphasic | Asymmetrical<br>Biphasic | Asymmetrical<br>Biphasic |
| Technology / Control<br>System | Microprocessor<br>Control,<br>Battery Powered | Microprocessor<br>Control,<br>Battery Powered | Microprocessor<br>Control,<br>Battery Powered |
| Patient Connection | Self-adhesive<br>Electrodes | Self-adhesive<br>Electrodes | Self-adhesive.<br>Electrodes |
| Safety | Limited Power,<br>Simple User Interface | Limited Power | Prescription Device |

Comparison of actual output under various loads and operating parameters shows no significant difference in the Pain-Aid and the predicate devices.

#### 7. Conclusions:

The PDI Works Pain-Aid has the same intended use and similar technological characteristics as the The I Dr Works I am 71d his also cansement (K060846) and Empi Select (K061650). cleared devices finclapedia massage Companies (six ) (six minor differences do not impact the safety or effectiveness of the device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

#### Public Health Service

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

MAR - 1 2012

PDI Works, LLC c/o Ms. Thu-Ha Duncan President 2150 South Lee Highway Cleveland, TN 37311

Re: K113037

Trade/Device Name: Pain-Aid Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Codes: NUH, NYN Dated: February 7, 2012 Received: February 14, 2012

Dear Ms. Duncan:

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

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Page 2 -- Ms. Thu-Ha Duncan

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

Kusia Alexander

Image /page/3/Picture/7 description: The image shows the handwritten word "for" in cursive script. The letter "f" has a large, looping descender that extends below the baseline, and the "o" and "r" are connected in a fluid, continuous stroke. The writing appears to be done with a pen or marker, and the ink is dark against a white background. The overall impression is one of casual, flowing handwriting.

Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

k113037 510(k) Number (if known):

Device Name:

Pain-Aid

Indications for Use:

To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back, and upper and lower extremities due to strain from exercise or normal household and work activities.

To be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number k 113037

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