Stimulator, Electrical, Transcutaneous, For Arthritis

NYN · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5890

Classification

FDA Product Code: NYN
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.5890
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through electrodes on patient's skin to provide relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis).

Market data

Cleared 510(k) submissions: 8
Registered establishments: 64

Source

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