(158 days)
The TerraQuant MQ2000 v.5 with the TQ-1TENS is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated, as well as for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain.
Not Found
While the provided document is a 510(k) clearance letter for a medical device (TerraQuant MQ2000 v.5 with TQ-1TENS), it does not contain the information requested about acceptance criteria and a study proving the device meets those criteria.
This letter is an FDA determination of "substantial equivalence" to a legally marketed predicate device, allowing the manufacturer to market the device. It focuses on regulatory compliance and does not describe the specific performance studies, acceptance criteria, or ground truth establishment that might have been part of the manufacturer's submission to support their claims.
Therefore, I cannot populate the table or answer the subsequent questions based solely on the provided text. The document acts as an approval, not a detailed technical report of the device's performance validation.
§ 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.