QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS, MODELS CO1A, CO1B, CO1C, CO1D, CO2A, CO2B

K993123 · United Pacific Co., Ltd. · ILY · Dec 17, 1999 · Physical Medicine

Device Facts

• Record ID: K993123
• Device Name: QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS, MODELS CO1A, CO1B, CO1C, CO1D, CO2A, CO2B
• Applicant: United Pacific Co., Ltd.
• Product Code: ILY · Physical Medicine
• Decision Date: Dec 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intented to use to emit energy in the infrared spectrum to provide topical heating for the purpose of temporarily elevating local tissue temperature. Intended to use for the temporary relief of minor muscle and joint stiffness, temporary relief of minor muscle strain spasm, temporary increase in local circulation where applied, and the relaxation of muscle.

Device Story

OK-Wide Band Spectrum Therapeutic Apparatus (Models CO1A-CO2B) emits infrared energy to provide topical heating. Device elevates local tissue temperature to relieve minor muscle/joint stiffness, muscle strain/spasm, and increase local circulation. Operated by user for over-the-counter applications. Output is thermal energy applied to the skin surface. Benefits include temporary pain relief and muscle relaxation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Infrared spectrum energy emitter; topical heating device; form factor includes multiple models (CO1A, CO1B, CO1C, CO1D, CO2A, CO2B).

Indications for Use

Indicated for individuals requiring temporary relief of minor muscle and joint stiffness, minor muscle strain/spasm, and temporary increase in local circulation via topical heating.

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

DEC 1 7 1999

Daniel Ye Hua President United Pacific Co., Ltd. 219 South Raymond Avenue Alhambra, CA 91801

Re: K993123

Trade Name: OK-Wide Band Spectrum Therapeutic Apparatus, Models CO1A, CO1B, CO1C, CO1D, CO2A and CO2B Regulatory Class: II Product Code: ILY Dated: September 18, 1999 · Received: September 20, 1999

Dear Mr. Hua:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 device in the Federal Register. Please note: this response to your premarket notification submission 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 -- Daniel Ye Hua

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

Sincerely, yours,

Nil R.P. Ogden

James E. Dillard III

for

Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 8 of 25

K993123 510(k) Number (if known):

QK- WIDE BAND SPECTRUM THERAPEUTIC APPARATUS Device Name:

Indications For Use:

Intented to use to emit energy in the infrared spectrum to provide topical heating for the purpose of temporarily elevating local tissue temperature.

Intended to use for the temporary relief of minor muscle and joint stiffness, temporary relief of minor muscle strain spasm, temporary increase in local circulation where applied, and the relaxation of muscle.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices

Division of General Restorative Devices
510(k) Number K93123

Prescription Asse (Par 21 CFR 801.109) ્વર

- Over-The-Counter Use

mat 1-2-96)

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