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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device powered exoskeleton
Regulation Description Powered lower extremity exoskeleton.
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.
Product CodePHL
Regulation Number 890.3480
Device Class 2


Premarket Reviews
ManufacturerDecision
CYBERDYNE, INC.
  SUBSTANTIALLY EQUIVALENT 1
EKSO BIONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXOATLET ASIA CO. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
RE WALK ROBOTICS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
REWALK ROBOTICS LTD. DBA LIFEWARD
  SUBSTANTIALLY EQUIVALENT 1
SAMSUNG ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WANDERCRAFT SAS
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2021 2 2
2022 2 2
2023 1 1
2024 6 6
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7 7
Insufficient Information 4 4
Retraction Problem 2 2
Fire 2 2
Battery Problem 2 2
Use of Incorrect Control/Treatment Settings 1 1
Mechanical Problem 1 1
Unexpected Therapeutic Results 1 1
Unstable 1 1
Improper or Incorrect Procedure or Method 1 1
Device Tipped Over 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bone Fracture(s) 6 6
No Clinical Signs, Symptoms or Conditions 3 3
Chest Pain 2 2
Pain 2 2
Limb Fracture 2 2
Sleep Dysfunction 1 1
Hip Fracture 1 1
Sepsis 1 1
Abrasion 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Thrombosis/Thrombus 1 1
Insufficient Information 1 1
Swelling/ Edema 1 1
Unspecified Vascular Problem 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Argo Medical Technologies Ltd II May-11-2021
2 WANDERCRAFT SAS II May-08-2025
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