(174 days)
Not Found
Not Found
No
The description focuses on light therapy, color therapy, and basic controls like a timer and intensity. There is no mention of AI, ML, data processing, or any features that would suggest intelligent algorithms are used.
Yes.
The device is indicated for "adjunctive use and providing temporary relief of minor muscle and joint pain" and helps to "temporarily increase local blood circulation," which are therapeutic claims.
No
The device description and intended use state that it is a lamp for temporary relief of pain and increased blood circulation, not for diagnosing conditions.
No
The device description clearly states it is a "color therapy mineral lamp" with "interchangeable multi colored heads," "lamp housing," "ergonomic stand," and "adjustable timer control." These are all physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Medica Health LTD, THERAGEM PROFESSIONAL T1002 is a lamp that applies light and color to the body for therapeutic purposes (pain relief, increased blood circulation). It does not involve the analysis of biological specimens.
Therefore, the device's intended use and description clearly indicate it is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medica Health LTD, THERAGEM PROFESSIONAL T1002 is a color therapy mineral lamp that helps to temporarily increase local blood circulation where applied, and temporarily relieve minor muscle, joint aches and pains through the use of light and color applied in a non-contact, non-heat manner. This color therapy Light device is designed for use at home, spa facilities and therapeutic centers. The Medica Health LTD, THERAGEM PROFESSIONAL T1002 provides interchangeable multi colored heads to the color therapy lamp in which there is no hazard for contacting the low ambient temperature colored heads. The color therapy multi-101 ved heads are secured within the lamp housing and utilizes an ergonomic stand which is designed for adjustable positioning by users in a domestic and/or professional environment. An adjustable timer control for safety functions is also incorporated into the THERAGEM PROFESSIONAL T1002. The Medica Health LTD, THERAGEM PROFESSIONAL T1002 allows the user control of the timer and intensity function thus assuming the safety level of device.
The Medica Health LTD, THERAGEM PROFESSIONAL T1002 is a lamp indicated for adjunctive use and providing temporary relief of minor muscle and joint pain. This device helps to temporarily increase local blood circulation where applied.
Product codes
ILY
Device Description
The Medica Health LTD, THERAGEM PROFESSIONAL T1002 is a color therapy mineral lamp that helps to temporarily increase local blood circulation where applied, and temporarily relieve minor muscle, joint aches and pains through the use of light and color applied in a non-contact, non-heat manner. This color therapy Light device is designed for use at home, spa facilities and therapeutic centers. The Medica Health LTD, THERAGEM PROFESSIONAL T1002 provides interchangeable multi colored heads to the color therapy lamp in which there is no hazard for contacting the contacting the low ambient temperature colored heads. The color therapy multi-101 ved heads are secured within the lamp housing and utilizes an ergonomic stand which is designed for adjustable positioning by users in a domestic and/or professional environment. An adjustable timer control for safety functions is also incorporated into the THERAGEM PROFESSIONAL T1002. The Medica Health LTD, THERAGEM PROFESSIONAL T1002 allows the user control of the timer and intensity function thus assuming the safety level of device.
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
home, spa facilities and therapeutic centers.
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
(081505
NOV 1 9 2008
510(K) Summary Preparation:
May 8th, 2008
Manufacturer's Contact Person:
Terri Cmorey Tel (954) 725-6493 Fax (954) 415-6059 Medica Health LTD 2842 Kelly Brooke Lane Deerfield Beach, Florida 33442
Trade Name: Theragem Professional T1002
Classification Name, Classification Number, Class, Classification Reference:
| Class. Name | Class. No | Class | 21CFR |
|---|---|---|---|
| Color Therapy Mineral Lamp | ILY | II | 890.5500 |
Regulation Name: Lamp, non-heating, for adjunctive use in pain therapy
There are no regulatory standards or special controls applicable for Special Controls: this device.
The Medica Health LTD, THERAGEM PROFESSIONAL Indications For Use: T1002 is a color therapy mineral lamp that helps to temporarily increase local blood circulation where applied, and temporarily relieve minor muscle, joint aches and pains through the use of light and color applied in a non-contact, non-heat manner. This color therapy Light device is designed for use at home, spa facilities and therapeutic centers. The Medica Health LTD, THERAGEM PROFESSIONAL T1002 provides interchangeable multi colored heads to the color therapy lamp in which there is no hazard for contacting the low ambient temperature colored heads. The color therapy multi-101 ved heads are secured within the lamp housing and utilizes an ergonomic stand which is designed for adjustable positioning by users in a domestic and/or professional environment. An adjustable timer control for safety functions is also incorporated into the THERAGEM PROFESSIONAL T1002. The Medica Health LTD, THERAGEM PROFESSIONAL T1002 allows the user control of the timer and intensity function thus assuming the safety level of device.
Contraindications: None
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medica Health, Ltd. % Terri Cmorey 2842 Kelly Brook Lane Deerfield Beach, Florida 33442
NOV 1 9 2008
Re: K081505
Trade/Device Name: Theragem T1002 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: November 7, 2008 Received: November 10, 2008
Dear Terri Cmorey:
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 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.
2
Page 2 - Terri Cmorey
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Presmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(K) Number (if known): K081505
Devise Name: Theragem T1002
Indications For Use:
The Medica Health LTD, THERAGEM PROFESSIONAL T1002 is a lamp indicated for adjunctive use and providing temporary relief of minor muscle and joint pain. This device helps to temporarily increase local blood circulation where applied.
Concurrence of CDHR of Device Evaluation (ODE)
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off) Division of General, Restorative And Neurological Devices
510(k) Number
Prescription Use _____________________________________________________________________________________________________________________________________________________________
or
Over-the-Counter Use
(Optional Format 1-2-96)
Nelon Ogle formen
(Division Sign-Off) (Division Sign of General, Restorative, Division rological Devices
510(k) Number K081505