510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PHLClass II

Powered Exoskeleton

21 CFR 890.3480 / Physical Medicine
FDA source (opens on fda.gov)

PHL is the FDA product code for Powered Exoskeleton, a class II device type, regulated under 21 CFR 890.3480. FDA's definition for this code reads: "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". As of , FDA records hold 25 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
PHL
Device name
Powered Exoskeleton
FDA 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.
Regulation
21 CFR 890.3480
Device class
Class II
Review panel
Physical Medicine
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
26
Ingested recalls
3

Clearances, product code PHL

By decision year
26 clearances under product code PHL with a decision year between 2014 and 2026, 2016 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code PHL by decision year
YearClearances
20141
20164
20172
20182
20192
20204
20211
20223
20232
20241
20252
20262

Applicants with the most clearances

Product code PHL
Applicants holding the most 510(k) clearances under product code PHL
ApplicantClearances
Ekso Bionics4
Wandercraft4
Cyberdyne Inc.3
Parker Hannifin Corp.3
Re Walk Robotics, Ltd.3
Lifeward, Inc.1
B-Temia, Inc.1
Exoatlet Asia Co., Ltd.1
Honda Motor Company, Ltd.1
Rewalk Robotics Ltd. dba Lifeward1

Companies listing this code with FDA

Companies whose registered establishments list this code