(222 days)
Intended for the relaxation of muscle spasms, temporary relief of minor muscle and joint aches, pain and stiffness, temporarily relief of minor pain and stiffness associated with arthritis, and to temporarily increase local blood circulation.
The HealthLight Footbed Model HL-FB is specifically indicated for treatment of the feet and lower legs.
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It appears there might be a misunderstanding or misinterpretation of the provided document. The document is a 510(k) Premarket Notification from the FDA for the HealthLight Footbed LED Light Therapy System Model HL-FB.
This document is a marketing clearance letter, not a clinical study report or a technical performance evaluation. It does not contain information about acceptance criteria, device performance against those criteria, or details of a study that proves the device meets specific performance metrics.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details) from this document.
The 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device, often without requiring new clinical performance studies of the type you're asking about if the technological characteristics and indications for use are similar.
If you have a different document that describes a study for this device, please provide that.
§ 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.