ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT

K060191 · Accelerated Care Plus Corp. · ILY · Jul 12, 2006 · Physical Medicine

Device Facts

• Record ID: K060191
• Device Name: ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT
• Applicant: Accelerated Care Plus Corp.
• Product Code: ILY · Physical Medicine
• Decision Date: Jul 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

This device is intended to 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 pains, minor arthritis pain and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue and to temporarily increase local blood circulation

Device Story

OmniProbe Infrared Lamp and OmniProbe 500 Control Unit emit infrared energy to provide topical heating. Device consists of LED pads (models 200LED-P2, 200LED-LE, 200LED-S, 200LED-K, 200LED-N, 200LED-E) powered by the 500 Control Unit or external medical-grade 5-12VDC power source. Used in clinical settings to elevate tissue temperature; provides temporary relief of minor muscle/joint pain, arthritis pain, muscle spasms, and stiffness; promotes muscle relaxation and local blood circulation. Operated by healthcare professionals.

Clinical Evidence

Bench testing only.

Technological Characteristics

Infrared lamp system; LED pads (multiple models); energy source: 5-12VDC isolated power supply; intended 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, minor arthritis pain, muscle spasm, stiffness, and to promote muscle relaxation and 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 2 2006

Accelerated Care Plus Corp. % Intertek Testing Services Mr. Neil E. Devine, Jr. Senior Staff Engineer 70 Codman Hill Road Boxborough, Massachusetts 01719

Re: K060191

Trade/Device Name: OmniProbe Infrared Lamp, OmniProbe 500 Infrared Lamp Control Unit Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: IL Y Dated: June 27, 2006 Received: June 28, 2006

Dear Mr. Devine:

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, Jrug, 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, TDA moral 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 not 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 requirements as set

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Page 2 - Mr. Neil E. Devine, Jr.

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. 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 [phone]. 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/industry/support/index.html .

Sincerely yours,

Herber Semenias

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section 4 - Indications for use

| 510(k) Number (if known): | K060191 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | OmniProbe Infrared Lamp<br>OmniProbe 500 Infrared Lamp Control Unit |
| LED Pad Model Numbers: | 200LED-P2, 200LED-LE, 200LED-S, 200LED-K,<br>200LED-N, and 200LED-E<br>For use with the OmniProbe 500 Control Unit<br>and/or any external medical grade power<br>source providing an isolated 5 to 12VDC power<br>source. |

## Indications for Use:

This device is intended to 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 pains, minor arthritis pain and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue and to temporarily increase local blood circulation

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulud Lumer

Division of General, Restorative, and Neurological Devices

**510(k) Number** *K060191*

This document is the property of Accelerated Care Plus and must be accounted for. Information here in is considered confidential. Do not reproduce it, reveal it to an unauthorized person or send it outside of Accelerated Care Plus without written authorization from Accelerated Care Plus.