DeviceClearance

Product code PHL— Physical Medicine

Atalante X

Classification name
Powered Exoskeleton
Device class
Class 2
Regulation
21 CFR 890.3480
Advisory panel
Physical Medicine
Total cleared
26
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PHL under 21 CFR 890.3480, via openFDA

Market context for product code PHL

FDA has cleared 26 devices under product code PHL between 2014 and 2026, filed by 14 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PHL

Recent clearances under product code PHL

Data sourced from openFDA. This site is unofficial and independent of the FDA.