PHASER-2000

K982546 · Diomedics, Inc. · ILY · Sep 22, 1998 · Physical Medicine

Device Facts

• Record ID: K982546
• Device Name: PHASER-2000
• Applicant: Diomedics, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Sep 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PAIN-X-2000 is indicated for use to emit energy in the Infrared Spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature.

Device Story

The Pain-X-2000 is a medical device designed to emit infrared energy for topical heating. It is available in multiple models (300, 600, 900, 1600, 2500, and 5700). The device functions by delivering infrared radiation to the skin surface to increase or sustain local tissue temperature. It is intended for use in clinical or home settings to provide therapeutic heat. Healthcare providers or patients use the device to manage conditions where topical heating is indicated. The output is thermal energy, which facilitates localized warming, potentially aiding in comfort or therapeutic outcomes.

Clinical Evidence

bench testing only

Technological Characteristics

Infrared spectrum energy emitter; multiple models (300, 600, 900, 1600, 2500, 5700); Class II device; product code ILY.

Indications for Use

Indicated for patients requiring topical heating to elevate or maintain tissue temperature via infrared energy emission.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 22 1998

Mr. Randall Everett President Diomedics, Inc. 3817 S.W. 15th Street Gainesville, Florida 32608

Re: K982546 Trade Name: Pain-X-2000 Models: 300, 600, 900, 1600, 2500 and 5700 Regulatory Class: II Product Codc: IL Y Dated: July 16, 1998 Received: July 21, 1998

Dear Mr. Everett:

We have reviewed your Section 510(k) notification of intent to market the device referenced ahove and we 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). You may, therefore, market the device, subject to the general control: 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 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 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 - Mr. Randall Everett

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 toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

f coole

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Officc of Devicc Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATION FOR USE STATEMENT

510(k) Number: _K982546

Device Name _PAIN-X-2000

Indications for Use:

The PAIN-X-2000 is indicated for use to emit energy in the Infrared Spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature.

(Please do not write below this line - Coutinue on another page if needed)

Concurrence of CDRH Office of Device Evaluation (ODE)

to cooclas

510kj Num

Prescription Use (per 21 CFR 801.109)

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Over-the Counter Use