SCRAMBLER ST 5 TENS DEVICE

K081255 · Competitive Technologies,Inc. · GZJ · Feb 20, 2009 · Neurology

Device Facts

• Record ID: K081255
• Device Name: SCRAMBLER ST 5 TENS DEVICE
• Applicant: Competitive Technologies,Inc.
• Product Code: GZJ · Neurology
• Decision Date: Feb 20, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Scrambler Therapy MC-5A TENS Device is indicated for: . Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain - Symptomatic relief of acute pain . - Symptomatic relief of post-operative pain .

Device Story

Multi-channel TENS device; generates and controls electrical stimulation impulses via stored program to provide pain relief. Used for symptomatic relief of chronic, intractable, post-surgical, post-traumatic, and acute pain. Device allows simultaneous treatment of multiple pain sites. Operated by healthcare professionals to deliver stimulation to patients.

Clinical Evidence

Bench testing only; device meets design and performance specifications.

Technological Characteristics

Multi-channel TENS device; electrical nerve stimulator; utilizes stored programs for stimulation impulse control.

Indications for Use

Indicated for symptomatic relief of chronic, intractable pain, post-surgical pain, post-traumatic acute pain, acute pain, and post-operative pain.

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

• Ito ES-160 (K051020)
• Neuro Wave 6 (K062003)

Submission Summary (Full Text)

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K081255

# 510(k) Summary for the Competitive Technologies, Inc. Scrambler Therapy MC-5A TENS Device (per 21CFR 807.92)

#### SUBMITTER/510(K) HOLDER 1.

FEB 2 0 2009

Competitive Technologies, Inc. 777 Commerce Drive Fairfield, CT 06825

Contact Person: Aris Despo Telephone: [phone]

Date Prepared: May 1, 2008

#### 2. DEVICE NAME

Proprietary Name: Scrambler Therapy MC-5A TENS Device Common/Usual Name: Electrical Nerve Stimulator Classification Names: Transcutaneous Electrical Nerve Stimulator

#### 3. PREDICATE DEVICES

- . Ito ES-160, K051020
- Neuro Wave 6, K062003 .

#### 4. DEVICE DESCRIPTION

The Scrambler Therapy MC-5A TENS Device is a multi-channel TENS device which allows simultaneous treatment of a number of pain sites. Stimulation impulses are generated and controlled according to a stored program to provide pain relief.

#### ഗ് INTENDED USE

The Scrambler Therapy MC-5A TENS Device is indicated for:

- . Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain

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- Symptomatic relief of acute pain .
- Symptomatic relief of post-operative pain .

#### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

Competitive Technologies, Inc. claims substantial equivalence of the Scrambler Therapy MC-5A TENS Device to the predicate devices based on the intended use, fundamental technology, and operation characteristics. A side-by-side comparison of the Scrambler Therapy MC-5A TENS Device and the cited predicate devices is included in the 510(k).

#### PERFORMANCE TESTING 7.

Testing of the Scrambler Therapy MC-5A TENS Device demonstrates that the device meets design and performance specifications.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Competetive Technologies, Inc. % Medical Device Consultants, Inc. Ms. Mary McNamara-Cullinane, RAC Senior Regulatory Affairs Specialist 49 Plain Street North Attleboro, Massachusetts 02760

FEB 2 0 2009

Re: K081255

Trade/Device Name: Competitive Technologies, Inc. Scrambler Therapy MC-5A TENS Device

Regulation Number: 21 CFR 882.5890

Regulation Name: Transcutaneous, electrical nerve stimulator for pain relief

Regulatory Class: II

Product Code: GZJ

Dated: February 6, 2009

Received: February 9, 2009

Dear Ms. McNamara-Cullinane:

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 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.

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### Page 2 - Ms. Mary McNamara-Cullinane, RAC

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

Mark N. Melkerson

Mark N. Me kerson Director 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): K081255

Device Name: Competitive Technologies, Inc. Scrambler Therapy MC-5A TENS Device.

Indications for Use:

The Scrambler Therapy MC-5A TENS Device is indicated for:

- . Symptomatic relief of chronic, intractable pain, post surgical and posttraumatic acute pain
- Symptomatic relief of acute pain .
- Symptomatic relief of post-operative pain .

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

SERVER PRES Division of General, Restorative, and Neurological Devices

510(k) Number 4081255