FAST START TENS, MODEL FS 3001

K041092 · Vision Quest Industries, Inc. · GZJ · Jul 1, 2004 · Neurology

Device Facts

• Record ID: K041092
• Device Name: FAST START TENS, MODEL FS 3001
• Applicant: Vision Quest Industries, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Jul 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TENS is used for symptomatic relief and management of chronic intractable pain, and/or as an adjunctive treatment in the management of post surgical and post traumatic acute pain.

Device Story

Fast Start TENS is a transcutaneous electrical nerve stimulator for pain management. Device delivers mild electrical impulses through skin via surface electrodes to modify pain perception. System includes device unit, 9V alkaline battery, electrodes, lead wires, and carrying case. Operated by patient or clinician to provide non-invasive, drug-free pain relief. Device features three operation modes (Conventional, Burst, Modulated) and twelve pre-set plus two customized programs. Output affects body's pain perception, assisting in management of chronic intractable pain and acute post-surgical or post-traumatic pain.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and performance standards comparison to the predicate device.

Technological Characteristics

Transcutaneous electrical nerve stimulator; 9V alkaline battery powered. Includes surface electrodes and lead wires. Three operation modes: Conventional, Burst, Modulated. Twelve pre-set and two customized programs. Meets mandatory performance standards for TENS devices.

Indications for Use

Indicated for symptomatic relief and management 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

• Classic TENS (K020437)

Submission Summary (Full Text)

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

# Koy1092

## 510 (k) SUMMARY

### JUL 01 2004

| Statement: | This summary of 510(k) substantial equivalence is<br>being submitted in accordance with the<br>requirements of 21 CFR 807.92 and can be used to<br>provide a substantial equivalence summary to<br>anyone requesting it from the Agency. |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Identification: | Vision Quest Industries, Inc.<br>18011 Mitchell South<br>Irvine, CA 92614<br>Contact Person: Jaime Pulley, VP of Quality<br>Assurance/Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] |
| Date Summary Prepared: | April 21, 2004 |
| Name of Device: | Proprietary Name: Fast Start® TENS<br>Common Name: (TENS) Transcutaneous Electrical<br>Nerve Stimulator |
| Classification Name: | Stimulator, Nerve, Transcutaneous, for pain relief<br>(GZJ) |
| Predicate Device Name: | Classic TENSTM<br>510(k) Number K020437<br>Mantra International Ltd.<br>Room L-5 15/F Blk B, Vigor Industrial<br>Building. 20 Cheung Tai Road<br>Tsing Yi, Hong Kong |

#### Device Description:

The Fast Start® TENS device is a transcutaneous electrical nerve stimulator that provides a non-invasive, drug free method of controlling acute and principally long term intractable pain. The device projects mild electrical impulses that are transmuted through the skin via surface electrodes to modify the body's pain perception. The FastStart ® TENS is made up of the device, one 9 V alkaline battery, a set of electrodes, two lead wires, and a carrying case.

#### Indications for Use

The TENS is used for symptomatic relief and management of chronic intractable pain,

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

## 510(k) Summary (continued)

and/or as an adjunctive treatment in the management of post surgical and post traumatic acute pain.

#### Comparison to Predicate

This device is similar to its predicate device, the Classic TENS, they both exhibit the same indications for use, technical characteristics and device specifications.

#### Conclusion

Designed with the same performance standards as its predicate, the Fast Start ® TENS does not raise any new questions in regards to safety and effectiveness. The device contains three modes of operation: Conventional, Burst, and Modulated. It is also equipped with twelve pre-set and two customized programs. The Fast Start TENS meets the mandatory performance standards.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

JUL 0 1 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jaime X. Pulley Vice President of Quality Assurance and Regulatory Affairs VisionOuest Industries. Inc. 18011 Mitchell South Irvine, California 92614

Re: K041092

Trade/Device Name: FastStart® TENS, Model FS 3001 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: April 21, 2004 Received: April 26, 2004

Dear Mr. Pulley:

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.

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

Page 2 -- Jaime X. Pulley

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/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

510(k) Number (if known): K041092

Device Name: __ Fast Start TENS

Indications For Use:

The TENS is used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post surgical and post traumatic acute 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)

Muriam C. Provost

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

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) Number_ K04/092