SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646

K020464 · Rolor Electronics Corp. · ILY · Sep 17, 2002 · Physical Medicine

Device Facts

• Record ID: K020464
• Device Name: SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646
• Applicant: Rolor Electronics Corp.
• Product Code: ILY · Physical Medicine
• Decision Date: Sep 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Temporarily increases local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains.

Device Story

Sanidad Far-Infrared Mini Lamp (FI-3646) is a therapeutic infrared lamp; emits far-infrared radiation to target tissue; intended for temporary relief of minor muscle/joint aches and pains and temporary increase of local blood circulation. Device operates as a heat-based modality; applied topically to the skin surface. Used in clinical or home settings; operated by patient or healthcare provider. Output is thermal energy; provides symptomatic relief through localized heating. No complex software or algorithmic processing involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Infrared lamp; Class II; Product Code ILY. Emits far-infrared radiation for therapeutic heating. Device is a standalone electrical unit. No software or complex electronic control systems described.

Indications for Use

Indicated for individuals seeking temporary relief of minor muscle and joint aches and pains and temporary increase of local blood circulation in the area of application.

Regulatory Classification

Identification

An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.

Special Controls

*Classification.* Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 1 7 2002

Rolor Electronics Corporation c/o Ke-Min Jen, Ph.D. Roc Chinese-European Industrial Research Society No. 58 Fu-Chiun Street Hsin-Chu City China (Taiwan)

Re: K020464

Trade/Device Name: Sanidad Far-Infrared Mini Lamp, FI-3646 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: IL Y Dated: July 26, 2002 Received: August 2, 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 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 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,

R. Merle Wilkerson

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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## 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):

Device Name: Sanidad Far-Infrared Mini Lamp, FI-3646

Indications For Use :

Temporarily increases local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains.

( 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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for 

(Division Sign-Off)

Division of General, Restorative

and Neurological Devices

| 510(k) Number | K020464 |
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| (Per 21 CFR 801.109) | |
| (Optional Format 1-2-96) | |