ELITE ELECTROMED L.I.T.E. 4/1

K053507 · Elite Electromedical · NHN · Mar 15, 2006 · Physical Medicine

Device Facts

• Record ID: K053507
• Device Name: ELITE ELECTROMED L.I.T.E. 4/1
• Applicant: Elite Electromedical
• Product Code: NHN · Physical Medicine
• Decision Date: Mar 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

THE L.I.T.E. 4/1 IS INDICATED FOR THE TREATMENT OF NECK AND SHOULDER PAIN OF MUSCULOSKELET OF ORIGIN.

Device Story

Elite Electromedical L.I.T.E. 4/1 is an infrared lamp device; intended for treatment of neck and shoulder pain of musculoskeletal origin. Device operates as an infrared lamp (21 CFR 890.5500); provides therapeutic heat/light energy to affected areas. Used in clinical settings; operated by healthcare professionals. Output consists of infrared radiation; intended to provide symptomatic relief of pain. Benefits include non-invasive pain management for musculoskeletal conditions.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device classification and intended use.

Technological Characteristics

Infrared lamp; Class II; Product Code NHN; 21 CFR 890.5500. Device utilizes infrared radiation for therapeutic purposes.

Indications for Use

Indicated for treatment of neck and shoulder pain of musculoskeletal origin.

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

MAR 1 5 2006

Elite Electromedical c/o Dr. Gary Huddleston, D.C. 4960 Wilson Drive Osage Beach, Missouri 65065

Re: K053507

Trade/Device Name: Elite Electromedical L.I.T.E. 4/1 Diode Laser Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: NHN Dated: February 28, 2006 Received: March 3, 2006

Dear Dr. Huddleston:

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 FIDA's issuance of a substantial equivalence determination docs 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 requirements 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 – Dr. Gary Huddleston

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/dsma/dsmamain.html

Sincerely yours.

e.Mell

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

Enclosure

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Elite Electromedical

Dr. Gary Huddleston, D.C. 4960 Wilson Dr. Osage Beach, MO. 65065 573-348-5982 fax: [phone] INDICATIONS FOR USE (KO53507)

510K NUMBER:

## K053507

DEVICE NAME:

ELITE ELECTROMEDICAL L.I.T.E. 4/1

INDICATIONS FOR USE:

THE L.I.T.E. 4/1 IS INDICATED FOR THE TREATMENT OF NECK AND SHOULDER PAIN OF MUSCULOSKELET OF ORIGIN.

Prescription Use

X ___ AND/OR Over-The-Counter-Use_____________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

el malle.

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

510(k) Number____ Ko5 3507