21 CFR 890.5775 — Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)

Physical Medicine (PM) · Part 890 Subpart F—Physical Medicine Therapeutic Devices · § 890.5775

Identification

An audio-visual stimulator for pain relief is a device intended to deliver light stimuli to the eyes and sound stimuli to the ears to provide pain relief. This device is intended to be used adjunctively to other modes of therapy to relieve pain. The Sana Device is indicated for patients aged 18 and older as an adjunct to other modes of therapy for temporary relief of neuropathic pain for use at home or in the clinic.

Classification Rationale

FDA concludes that this device should be classified into Class I. FDA believes that class I (general) controls provide reasonable assurance of the safety and effectiveness of the device type.

Product Codes