LIGHT PATCH

K993686 · Bioscan, Inc. · ILY · Jul 18, 2000 · Physical Medicine

Device Facts

• Record ID: K993686
• Device Name: LIGHT PATCH
• Applicant: Bioscan, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Jul 18, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Use wherever hot applications are desirable for personal comfort and whenever recommended by a licensed medical professional. Provides temporary relief of minor aches and pains in muscles and joints. Aids in the relaxation of muscles. Helps provide for a temporary improved range and freedom of motion due to muscle relaxation and temporary minor pain relief. Provides a temporary increase in local blood circulation.

Device Story

Light Patch is a thermal therapy device providing localized heat application. Used for personal comfort or as recommended by medical professionals to alleviate minor muscle/joint pain, promote muscle relaxation, improve range of motion, and increase local blood circulation. Operated by the patient for home use. Device functions as a heat source; no complex data processing or algorithmic components involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Thermal therapy device; form factor designed for topical application. No electronic sensing, connectivity, or software components. Sterilization and material specifications not detailed in the provided text.

Indications for Use

Indicated for individuals seeking temporary relief of minor muscle and joint aches and pains, muscle relaxation, improved range of motion, and increased local blood circulation via heat 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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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 1 8 2000

Butch Smith, Vice President BioScan, Inc. 6 Walden Road Corrales, New Mexico 87048

Re: K993685 and K993686 Trade Name: BioPack and Light Patch Regulatory Class: II Product Code: ILY Dated: April 5, 2000 Received: April 19, 2000

Dear Mr. Smith:

We have reviewed your Section 510(k) notification of intent to market the devices referenced we have reviewed four bocker broes are substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate use stated in the encrosure) to regary enactment date of the Medical Device Amendments, or to conninered prof to May 20, 1978, are excordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the devices, subject to the general controls and Cosmodo Free (110). The general controls provisions of the Act include requirements for provisions of the Fred "The of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major ( remaince i ffecting your devices can be found in the Code of Federal Regulations, Title 21, regulations and outling your as a vivalent determination assumes compliance with the Current Farts 600 to 65%. I reactice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspotions, the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Butch Smith

This letter will allow you to begin marketing your devices as described in your 510(k) premarket I mis letter will anow you to obgen makes antial equivalence of your devices to legally marketed nothleate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and If you desire spoonly arriver diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your devices, [phone]. Naturaliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small monifacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Dune R. bochner

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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### 510(k) Number (if known): K993686

Device Name: Light Patch

Indications for Use:

- Use wherever hot applications are desirable for personal comfort and whenever A recommended by a licensed medical professional
- > Provides temporary relief of minor aches and pains in muscles and joints
- > Aids in the relaxation of muscles
- > Helps provide for a temporary improved range and freedom of motion due to muscle relaxation and temporary minor pain relief
- > Provides a temporary increase in local blood circulation

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109) OR

Over the Counter Use: (Optional Format 1-2-96)

Danne R. Lochness
Division Sign-Off

vision Sign-Off)
vision of General Restorative Devices
(k) Number K993686