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.

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 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.

AI/ML Overview

The provided text is a 510(k) summary and FDA clearance letter for the "Theragem Professional T1002" color therapy mineral lamp. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document states:

"There are no regulatory standards or special controls applicable for this device." This implies that the device was cleared based on substantial equivalence to a predicate device, rather than meeting specific performance criteria demonstrated through a clinical study.
The FDA clearance letter refers to the "Theragem T1002" as an "Infrared lamp" under regulation 21 CFR 890.5500, which is classified as Class II. However, the 510(k) summary itself lists "Color Therapy Mineral Lamp" and Class II under regulation 890.5500. This regulation, 21 CFR 890.5500, describes "Infrared lamp for heating". The discrepancy is resolved in the FDA letter, which correctly identifies the classification and regulation number.
The indications for use are for "adjunctive use and providing temporary relief of minor muscle and joint pain" and to "temporarily increase local blood circulation where applied." These are typical indications for devices cleared through substantial equivalence without requiring extensive clinical trials demonstrating efficacy against specific endpoints, especially if the predicate device already has those indications.

Therefore, I cannot populate the table or provide answers to the requested study-related information because the provided text does not include any performance data, acceptance criteria, or details of a study as you've described. The 510(k) process often relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials with acceptance criteria for performance.

Summary

{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:

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 _____________________________________________________________________________________________________________________________________________________________

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

Regulation Number and Section

N/A