(87 days)
Not Found
No
The summary describes a simple infrared therapy device with no mention of AI or ML capabilities.
Yes
The device is marketed for therapeutic purposes, specifically for temporary relief of pain and stiffness, temporary increase in local blood circulation, and temporary relief of muscle spasms, which are all indications of a therapeutic device.
No
The device description and intended use clearly state that it is an infrared therapy device designed to provide therapeutic effects ( जैसे, pain relief, increased circulation, etc.) rather than to diagnose medical conditions.
No
The device description clearly states it is a hardware device that emits infrared energy through LEDs.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for therapeutic purposes, specifically for pain relief, increased blood circulation, and relief of muscle spasms and pain associated with various conditions. This involves applying energy to living tissue.
- Device Description: The device description confirms it's an infrared therapy device that emits energy to elevate tissue temperature. This is a physical therapy modality, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
BioCare system's infrared therapy products emit energy in the infrared spectrum for the purposes of elevating tissue temperature; for temporary relief / reduction of minor muscular pain, minor muscular back pain and minor joint pain and stiffness. Additionally, these products are intended to provide a temporary increase in local blood circulation and provide temporary relief of muscle spasms and minor sub-acute or chronic pain associated with arthritis, sprains or strains.
Product codes
ILY
Device Description
The PremIR 818 is an over-the-counter, infrared-therapy device, designed to emit energy at infrared frequencies to provide topical heating. The PremIR 818 provides infrared therapy through infrared frequencies to provide topical heating and that delivers infrared light for the purposes of elevating tissue temperature to living tissue in the body. Infrared light is delivered to the user via Gallium Aluminum Arsenide (GaAlAs) Light Emitting Diodes (LEDs) distributed under the face plate of the PremIR 818. The LEDs used in the PremIR have average wavelengths of between 880 nm and 884 nm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
DEC 1 3 2004
9. 510(k) Summary
510(k) SUMMARY BIOCARE SYSTEMS, INC - PremIR 818
SUBMITTER INFORMATION
| Company name / address: | Reglera LLC
518 17th Street
Suite 1350
Denver, CO 80202 |
|--------------------------------|--------------------------------------------------------------------------------------------------|
| 510(k) contact name / numbers: | Clay Anselmo
Phone: 800-341-4255 or 303.223.4303
Fax: 303-832-6700
anselmoc@reglera.com |
| Date summary prepared: | 8/3/04 |
Trade names:
PremIR 818
PremIR 818 Infrared Therapy Device Common name:
Infrared Lamp Classification name:
PREDICATE DEVICES
Trade name: LightForce Super Nova 510(k) number: K022888 and K001179
Trade name: Quantum WARP 10 Light Delivery System 510(k) number: K032229
DEVICE DESCRIPTION
The PremIR 818 is an over-the-counter, infrared-therapy device, designed to emit energy at infe i reful o to is an over the osanton and one of the PremIR 818 provides infrared therapy through infrared frequencies to provide topical houng. In and that delivers infrared light for the purposes the use of an ennoicht und odor to acat living tissue in the body. Infrared light is delivered to the of elevating tissue tomporation to to a Arsenide (GaAlAs) Light Emitting Diodes (LEDs) distributed under the face plate of the PremIR 818. The LEDs used in the PremIR have average wavelengths of between 880 nm and 884 nm.
INDICATIONS FOR USE
BioCare system's infrared therapy products emit energy in the infrared spectrum for the purposes of elevating tissue temperature; for temporary relief / reduction of minor muscular pain, minor or clevailing trough tomperature pain and stiffness. Additionally, these products are intended
1
to provide a temporary increase in local blood circulation and provide temporary relief of muscle spasms and minor sub-acute or chronic pain associated with arthritis, sprains or strains.
TECHNOLOGICAL CHARACTERISTICS COMPARISON
The following primary characteristics of the PremIR 818 device are substantially equivalent to the LightForce Super Nova device.
- t Indications for Use
- Wavelength of the light utilized .
- Waveform .
- Power supply and specifications ●
- Energy source .
- Number of LEDs .
- . Device type
The following primary characteristics of the PremIR 818 device are substantially equivalent to the Quantum WARP 10 device.
- Indications for Use .
- . Wavelength of the light utilized
- . Energy source
- Energy delivery .
- . Device type
- Power Output .
PERFORMANCE DATA
35 – 56 mW/cm2 Delivered Energy: Central Wavelength: 884 nm Mean Wavelength: 881 nm Minimum Wavelength: 831 nm Maximum Wavelength: 937 nm
Complies with IEC 601-1-2, Electromagnetic Compatibility Complies with UL 60601-1, General Electrical Safety
Maintains skin (treatment) temperatures between 40 and 45 degrees C for greater than 10 minutes
CONCLUSION
The PremIR 818 is substantially equivalent to the LightForce Super Nova and the Quantum WARP 10 Light Delivery System.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 2004
Reglera LLC C/o Mr. Clay Anselmo 518 17th Street Suite 1350 Denver, Colorado 80202
Re: K042532
Trade/Device Name: PremIR 818 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: August 2, 2004 Received: September 17, 2004
Dear Mr. Anselmo:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associou in the encreations of the enactment date of the Medical Device Amendments, or to conimered pror to may 20, 20, 2019 11:31 accordance with the provisions of the Federal Food, Drug, de nees that have been receasined require approval of a premarket approval application (PMA). and Cosmette (110) that to novice, 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 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. Clay Anselmo
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milliken
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): | K042532 |
|---|---|
| Indications for Use |
Device Name: PremIR 818
Indications for Use:
BioCare system's infrared therapy products emit energy in the infrared spectrum for the purposes of elevating tissue temperature; for temporary relief / reduction of minor muscular pain, minor muscular back pain and minor joint pain and stiffness. Additionally, these products are intended to provide a temporary increase in local blood circulation and provide temporary relief of muscle spasms and minor sub-acute or chronic pain associated with arthritis, sprains or strains.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use xxx (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
for (Division Sign-Off)
Division of General, Restorative, Page _ of _
and Neurological Devices
(Posted November 13, 2003)
510(k) Number K042532
PremIR 818 510(k)