MHS MED LIGHT 1000

K021956 · Micro Health Systems, Inc. · ILY · Aug 13, 2002 · Physical Medicine

Device Facts

• Record ID: K021956
• Device Name: MHS MED LIGHT 1000
• Applicant: Micro Health Systems, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Aug 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Micro Health Systems, MHS MED LIGHT 1000 is a device which helps to temporarily increase local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains through the use of heat applied in a non-contact manner. Aiming means adjustable by users from the heat ceramic filament in which there is no hazard for contacting high temperature lamps. An adjustable timer control for safety functions is also incorporated into the MHS MED LIGHT 1000. The Micro Health System MHS MED LIGHT 1000 cooling method is related to temperature of the enclosure, and the enclosure, and the enclosure temperatures of the three devices listed in the comparison table are assured. According to the different wattages and the maximum temperatures, we also know the ceramic type lamp of the AP-2018 is more efficient that the other two lamps. The maximum temperatures for these three devices listed in the comparison table are above 100 degrees Fahrenheit, and can reach the intended results. The timer controls and the continuous intensity controls exist on the MHS MED LIGHT 1000. The user can control the timer function and intensity control the receiving heat amount, thus assuming the safety level.

Device Story

MHS Med Light 1000 is an infrared lamp device for non-contact heat therapy. Device utilizes a ceramic filament to emit heat; user-adjustable aiming mechanism; adjustable timer and intensity controls for safety. Used in home or clinical settings; operated by patient or clinician. Device provides localized thermal energy to skin surface; heat increases local blood circulation; provides temporary relief of minor muscle and joint aches/pains. Safety ensured via enclosure temperature management and user-controlled intensity/duration settings.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Infrared lamp; ceramic filament heat source; non-contact application. Features adjustable timer and continuous intensity controls. Enclosure design manages cooling. Operates via electrical power. No software or connectivity.

Indications for Use

Indicated for temporary increase of local blood circulation and temporary relief of minor muscle and joint aches and pains in general population.

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.

Predicate Devices

• AP-2018 (not otherwise specified)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 3 2002

Mr. Robert Barnes President Micro Health Systems, Inc. 407 Dover Lane Parkland, Florida 33067

Re: K021956

> Trade/Device Name: MHS Med Light 1000 Regulation Number: 890.5500 Regulation Name: Infrared Lamp Regulatory Class: II Product Code: ILY Dated: July 29, 2002 Received: August 7, 2002

Dear Mr. Barnes:

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. Iisting 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 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 - Mr. Robert Barnes

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

for Mark N. Millerson

Celia 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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510(K) Number (if known): KO21956

Devise Name: MHS MED LIGHT 1000

Indications For Use:

The Micro Health Systems, MHS MED LIGHT 1000 is a device which helps to temporarily increase local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains through the use of heat applied in a non-contact manner. Aiming means adjustable by users from the heat ceramic filament in which there is no hazard for contacting high temperature lamps. An adjustable timer control for safety functions is also incorporated into the MHS MED LIGHT 1000. The Micro Health System MHS MED LIGHT 1000 cooling method is related to temperature of the enclosure, and the enclosure, and the enclosure temperatures of the three devices listed in the comparison table are assured. According to the different wattages and the maximum temperatures, we also know the ceramic type lamp of the AP-2018 is more efficient that the other two lamps.

The maximum temperatures for these three devices listed in the comparison table are above 100 degrees Fahrenheit, and can reach the intended results. The timer controls and the continuous intensity controls exist on the MHS MED LIGHT 1000. The user can control the timer function and intensity control the receiving heat amount, thus assuming the safety level.

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Concurrence of CDHR of Device Evaluation (ODE)

(Division Sign- Off) Division Of Reproductive, Abdominal, ENT. And Radiological Devices

510(k) Number

Prescription Use

or

Over-the-Counter Use ✓

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

L. Mark N. Millman

2:12 r and Neurological Devices

510(k) Number K021956