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FDA PRODUCT CODE · CLASS II

PHL — Powered Exoskeleton

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 890.3480
MEDICAL SPECIALTY
Physical Medicine
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES

Recent clearances

K250904Wandercraft SAS · 510k2025-10-24
K241822Rewalk Robotics Ltd. Dba Lifeward · 510k2025-03-12

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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