External Upper Limb Tremor Stimulator

QBC · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5897

Classification

FDA Product Code: QBC
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.5897
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

An external upper limb tremor stimulator is a prescription device which is placed externally on the upper limb and designed to aid in tremor symptom relief of the upper limb.

Market data

Cleared 510(k) submissions: 9
Registered establishments: 4

Source

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