(356 days)
The Tender Touch is intended to emit energy in the visible and infrared spectrum to provide heating for the purpose of elevating tissue temperature for the temporary relief of joint pain, muscle stiffness, minor arthritis pain or muscle spasm; the temporary increase in local blood circulation and the temporary relaxation of muscle.
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I am sorry but this document does not contain the information you are looking for. This document is a letter from the FDA to Sometech Corporation regarding the 510(k) premarket notification for their device, Tender Touch. It states that the device is substantially equivalent to legally marketed predicate devices and outlines general controls and regulations. It also includes the official indications for use for the Tender Touch device. This document does not provide details about acceptance criteria, study methodologies, or performance metrics.
§ 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.