Powered Exoskeleton

PHL · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.3480

Classification

FDA Product Code: PHL
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 890.3480
Review panel: NE
Medical specialty: Physical Medicine
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A powered exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened lower extremity limb(s) for medical purposes.

Market data

Cleared 510(k) submissions: 24
Registered establishments: 8

Source

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