(61 days)
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No
The description focuses on heat application, adjustable controls (timer, intensity), and safety features, with no mention of AI or ML terms or functionalities.
Yes
The device is used to temporarily increase blood circulation, and relieve muscle and joint aches and pains, which are therapeutic claims.
No
The device description and intended use state that it temporarily increases local blood circulation and relieves minor muscle and joint aches and pains through heat application, which are therapeutic functions, not diagnostic ones.
No
The device description clearly details physical components like a heat ceramic filament, adjustable aiming means, a timer control, and an enclosure with a cooling method, indicating it is a hardware device that applies heat.
Based on the provided information, the Micro Health Systems, MHS MED LIGHT 1000 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The intended use and device description of the MHS MED LIGHT 1000 clearly state that it applies heat externally to the body to increase local blood circulation and relieve pain. It does not involve the analysis of biological specimens.
- The device description focuses on the physical application of heat and its effects on the body. There is no mention of analyzing samples or providing diagnostic information based on biological markers.
Therefore, the MHS MED LIGHT 1000 falls under the category of a therapeutic or physical medicine device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
ILY
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 890.5500 Infrared lamp.
(a)
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.(b)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or wave.
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.
1
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
2
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.
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
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