Exercise Equipment, Powered, Emg-Triggered

OAL · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.1375

Classification

FDA Product Code: OAL
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 890.1375
Review panel: PM
Medical specialty: Physical Medicine
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

To provide rehabilitation (e.G., increasing range of motion, muscle re-education) through emg-triggered powered exercise. Increasing range of motion and muscle re-education.

Market data

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

Source

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