SANIDAD TENS-DUO MODE GP8016N

K021430 · Rolor Electronics Corp. · GZJ · Dec 2, 2002 · Neurology

Device Facts

• Record ID: K021430
• Device Name: SANIDAD TENS-DUO MODE GP8016N
• Applicant: Rolor Electronics Corp.
• Product Code: GZJ · Neurology
• Decision Date: Dec 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Sanidad TENS-Duo Mode GP8016N is a transcutaneous electrical nerve stimulator (TENS). Device delivers electrical impulses to patient via electrodes to provide pain relief. Operated by patient at home or in hospital following prescription/instruction by qualified healthcare professional. Device functions as pain management tool for chronic, intractable, post-surgical, or post-traumatic pain. Output consists of electrical stimulation parameters controlled by user settings.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Transcutaneous electrical nerve stimulator (TENS). Class II device. Operates via electrical stimulation for pain relief. Form factor is a portable electronic unit. No specific materials, software algorithms, or connectivity standards are detailed in the provided documentation.

Indications for Use

Indicated for symptomatic relief and management of chronic, intractable pain and adjunctive treatment of 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)

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.

DEC 02 2002

Dr. Jen. Ke-Min ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu Citv. Taiwan. ROC

## Re: K021430

Trade/Device Name: Sanidad TENS-Duo Mode GP8016N Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: October 18, 2002 Received: October 25, 2002

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

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

Page 2 - Dr. Jen

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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

for 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

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

## ROLOR ELECTRONICS CORPORATION SANIDAD HEALTH INDUSTRIES, INC.

No. 274, Nanking E. Road, Sec. 5, Taipei, Taiwan, R.O.C. P.O. Box 46-379 TEL: [phone], FAX: [phone] Email: [e-mail], http://www.rolor.com

| Indications for Use Statement |
|-------------------------------|
|-------------------------------|

| Ver/ 3-4/24/96 |
|----------------|
|----------------|

| Applicant: | ROLOR ELECTRONICS CORPORATION |
|----------------------------|-------------------------------|
| 510(k) Number ( if known): | K621430 |
| Device Name: | Sanidad TENS-Duo Mode GP8016N |

| Indications For Use : |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <ul><li>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.</li><li>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.</li></ul> |

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
|--------------------------------------------------------|

| | Miriam C. Provost |
|--|-----------------------------------------------------------------------|
| | Division of General, Restorative and Neurological Devices |
| | (Per 21 CFR 801.109) |

| | K621430 |
|--|---------|
|--|---------|

| | ( Optional Format 1-2-96) |
|--|---------------------------|
|--|---------------------------|