BESMED VARIOUS MODELS OF TENS, BE-550/BE-660

K031374 · Besmed Health Business Corp · GZJ · Nov 28, 2003 · Neurology

Device Facts

• Record ID: K031374
• Device Name: BESMED VARIOUS MODELS OF TENS, BE-550/BE-660
• Applicant: Besmed Health Business Corp
• Product Code: GZJ · Neurology
• Decision Date: Nov 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

it is used for the symptomatic relief and management of ● chronic, intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems. Clinical settings: should be used under the instruction or prescription by qualified health professionals prior to the applications of the device at home or hospital facilities.

Device Story

Besmed TENS models BE-550/BE-660 are transcutaneous electrical nerve stimulators. Device delivers electrical impulses via electrodes to skin to provide pain relief. Operated by patients in home or hospital settings under physician instruction/prescription. Intended for management of chronic intractable pain and adjunctive treatment of post-surgical/post-traumatic acute pain. Device provides symptomatic relief through electrical stimulation.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device characteristics.

Technological Characteristics

Transcutaneous electrical nerve stimulator (TENS). Class II device. Product code GZJ. Operates via electrical stimulation for pain management. Technical specifications and materials not detailed in provided text.

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. For use under instruction or prescription by qualified health professionals in home or hospital settings.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 28 2003

Besmed Health Business Corp. C/o Ke-Min Jen, Ph.D. R.O.C. Chinese-European Industrial Research Society No. 58. Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300

Re: K031374

Trade Name: Besmed various models of TENS, BE-550 / BE-660 Regulation Numbers: 21 CFR 882.5890 Regulation Names: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Codes: GZJ Dated: September 5, 2003 Received: September 15, 2003

Dear Dr. Jen:

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 - Ke-Min Jen, Ph.D.

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,

Mark N. Millerson

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

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## 4. INDICATIONS FOR USE STATEMENT

Applicant : Besmed Health Business Corp.

510(k) Number :

Device Name : Besmed various models of TENS, BE-550 / BE-660

## Indications for Use :

- Specific indications: it is used for the symptomatic relief and management of ● chronic, intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
- Clinical settings: should be used under the instruction or prescription by qualified health professionals prior to the applications of the device at home or hospital facilities.

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

Prescription Use OR Per 21 CFR 801.109 Format 1-2-96) i. Restorative Curological () Number.