(174 days)
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.
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 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.
§ 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.