NEWLIFE SCIENCES LLC, MODEL TMR

K070474 · Newlife Sciences, LLC · GZJ · Apr 25, 2007 · Neurology

Device Facts

• Record ID: K070474
• Device Name: NEWLIFE SCIENCES LLC, MODEL TMR
• Applicant: Newlife Sciences, LLC
• Product Code: GZJ · Neurology
• Decision Date: Apr 25, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The NewLife Sciences LLC, Model TMR, is intended for temporary symptomatic relief of chronic intractable pain, and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Device Story

NewLife Sciences Model TMR is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief. System components include a control console, two treatment probes (electrodes), and a security cartridge. Device operates on 115V wall current. Used in medical settings under physician supervision; clinician applies low electrical current to painful tissue and trigger points via probes. Output provides electrical stimulation to nerves to manage pain. Benefits include temporary symptomatic relief of chronic intractable pain and adjunctive management of acute post-surgical or post-traumatic pain.

Clinical Evidence

Bench testing only. Systematically tested to demonstrate fulfillment of design and performance specifications.

Technological Characteristics

Transcutaneous Electrical Nerve Stimulator (TENS). Components: control console, two treatment probes, security cartridge. Power source: 115V wall current. Class II device (21 CFR 882.5890).

Indications for Use

Indicated for temporary symptomatic relief of chronic intractable pain and as adjunctive treatment for post-surgical and post-traumatic acute pain in patients requiring pain management.

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

• MediPhysics Pain Centers of America (K032928)
• Empi Epix VT TENS (K970203)
• Therapeutic Devices Inc. TENS (K894127)
• Medical Devices Matrix 1 TENS model 4700s (K895473)
• Well Life Health Care Mini TENS WL-2403 (K020020)
• CERFAR Primo (K020803)
• Electro-Acuscope 85 (K883911)

Submission Summary (Full Text)

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K070474

## 510(k) Summary NewLife Sciences TMR

APR 2 5 2007

#### 1. SPONSOR

NewLife Sciences LLC 51 Pondview Dr Merrimack, NH 03054

Contact Person: Ronald Weinstock Telephone: [phone]

Date Prepared: December 11, 2006

#### 2. DEVICE NAME

| Proprietary Name: | NewLife Sciences LLC, Model TMR |
|----------------------|--------------------------------------------------------------------|
| Common/Usual Name: | Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief. |
| Classification Name: | Class II; 21 CFR 882.5890; Product Code GZJ |

## 3. PREDICATE DEVICES

MediPhysics Pain Centers of America (K032928) Empi Epix VT TENS (K970203) Therapeutic Devices Inc. TENS (K894127) Medical Devices Matrix 1 TENS model 4700s (K895473) Well Life Health Care Mini TENS WL-2403 (K020020) CERFAR Primo (K020803) Electro-Acuscope 85 (K883911)

#### 4. DEVICE DESCRIPTION

The NewLife Sciences LLC, Model TMR, consists of a control console, two Treatment Probes (electrodes), and a Security Cartridge. The system operates on 115V wall current. Treatment, intended to take place under the supervision of a physician in a medical setting, consists of applying very low current to painful tissue and associated trigger points with the Treatment Probes.

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#### INTENDED USE న్.

The NewLife Sciences LLC, Model TMR, is intended for temporary symptomatic relief of chronic intractable pain, and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

## 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

NewLife Sciences LLC, Model TMR is identical to the MediPhysics Pain Centers of America (K032928) which has been determined to be substantially equivalent to the cited predicate devices based on intended use, indications for use, design characteristics, and technological characteristics and that the differences between the NewLife Sciences TMR ard cited predicate devices are minor and raise no new issues of safety or effectiveness.

## 7. PERFORMANCE TESTING

The NewLife Sciences TMR has been systematically tested and test results demonstrate that it fulfills design and performance specifications.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NewLife Sciences, LLC C/O Danial W. Lehtonen Staff Engineer Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 Twinsburg, Ohio 44087

APR 2 5 2007

Re: K070474

Trade/Device Name: Model TMR Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief Regulatory Class: Class II Product Code: GZJ Dated: March 29, 2007 Received: March 30, 2007

Dear Mr. Lehtonen:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

for Pelderm
Mark N. Melkerson
Director
O ep D.fscgol
4/25/07

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): _________________________________________

Device Name: NewLife Sciences LLC, Model TMR

Indications For Use: The NewLife Sciences LLC, Model TMR, is intended for temporary symptomatic relief of chronic intractable pain, and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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D.D

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

LG1097

**510(k) Number**