Thermal System For Insomnia

PLU · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5700

Classification

FDA Product Code: PLU
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.5700
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A thermal system for insomnia is a prescription device for use in patients with insomnia that is used to apply a specified temperature to the skin surface.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown