# Powered Exoskeleton
> **Product code: 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
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PHL)
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