BIOPACK

K993685 · Bioscan, Inc. · ILY · Jul 18, 2000 · Physical Medicine

Device Facts

• Record ID: K993685
• Device Name: BIOPACK
• 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

BioPack is a thermal therapy device providing localized heat application. Used for temporary relief of minor muscle/joint aches, muscle relaxation, and increased local blood circulation. Operates as a hot pack for personal comfort or professional recommendation. Applied topically to the affected area by the user or clinician. Benefits include improved range of motion and pain relief through heat-induced muscle relaxation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Thermal therapy device designed for heat application. Form factor and materials not specified in the provided documentation. Non-powered, passive thermal delivery.

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. Suitable for use wherever hot applications are recommended by a medical professional.

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

## 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 above and we have determined the devices are 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). You may, therefore, market the devices, 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 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 regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice 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 comply with 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 ocgin mantany i equivalence of your devices to legally marketed notifications. The PDF Imaling of sassion 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 specific acres in the other ostic devices), please contact the Office of Compliance at additionally 607.10 101 = 10 = 10 = 10 = 10 = 10 = 10 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 [phone]. Traditionally, and the 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 mormation on your responsive at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Dwine 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): K993685

Device Name: BioPack

Indications for 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 公
- > 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)

Dmane R. Vochra.

(Division Sign-Off) Division of General Restorative Devices 510(k) Number K9936 85