EM PROBE, EM PAD

K024361 · Em Probe, Inc. · ILY · Oct 9, 2003 · Physical Medicine

Device Facts

• Record ID: K024361
• Device Name: EM PROBE, EM PAD
• Applicant: Em Probe, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Oct 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EM-PROBE is indicated for use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, arthritis, muscle spasm, and to increase local blood circulation.

Device Story

EM-PROBE is an infrared lamp device; emits infrared energy to elevate tissue temperature; used for temporary relief of minor muscle/joint pain, arthritis, muscle spasms, and to increase local blood circulation; operated by clinician or patient; provides non-invasive thermal therapy.

Clinical Evidence

Bench testing only.

Technological Characteristics

Infrared lamp; emits energy in the infrared spectrum for topical heating; Class II device (21 CFR 890.5500).

Indications for Use

Indicated for patients requiring topical heating for temporary relief of minor muscle and joint pain, arthritis, muscle spasm, and to increase local blood circulation.

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

OCT - 9 2003

Glen A. Gordon, M.D. EM PROBE, Inc. 1501 Old Gardiner Road Sequim, WA 98382

Re: K024361

Trade/Device Name: EM-PROBE Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: June 30, 2003 Received: July 14, 2003

Dear Dr. Gordon:

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 reguirements 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 - Glen A. Gordon, M.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), please contact the Office of Compliance at (301) 594-. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

L. Mark N. Milliman

elia 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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Wednesday, March 26, 2003

Applicant- EM-PROBE Inc 510k Number----K024361 Device Name- EM-PROBE Indications for Use:

## Statement of Indications for Use

The EM-PROBE is indicated for use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, arthritis, muscle spasm, and to increase local blood circulation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Per 21 CFR 801.109

Division Signature

510K Number K024361

Mark N. Millerson

: :

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K0 24361