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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
ARGO MEDICAL TECHNOLOGIES, INC.
  GRANTED 1
B-TEMIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
CYBERDYNE, INC.
  SUBSTANTIALLY EQUIVALENT 3
EKSO BIONICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
EXOATLET ASIA CO. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
HONDA MOTOR COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PARKER HANNIFIN CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
PARKER-HANNIFIN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
RE WALK ROBOTICS , LTD.
  SUBSTANTIALLY EQUIVALENT 3
REWALK ROBOTICS LTD. DBA LIFEWARD
  SUBSTANTIALLY EQUIVALENT 1
REWALK ROBOTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SAMSUNG ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
US BIONICS, INC. (DBA SUITX)
  SUBSTANTIALLY EQUIVALENT 1
WANDERCRAFT SAS
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2016 4 4
2017 8 8
2018 21 21
2020 3 3
2021 2 2
2022 2 2
2023 1 1
2024 6 6
2025 6 6
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Human-Device Interface Problem 6 6
Insufficient Device Problem Information 4 4
Fire 2 2
Battery Problem 2 2
Retraction Problem 2 2
Unstable 1 1
Mechanical Problem 1 1
Device Tipped Over 1 1
Component Missing 1 1
Use of Incorrect Control/Treatment Settings 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bone Fracture(s) 33 33
Swelling 5 5
No Clinical Signs, Symptoms or Conditions 3 3
Limb Fracture 3 3
Bruise/Contusion 3 3
Hip Fracture 2 2
Chest Pain 2 2
Pain 2 2
Fracture, Arm 1 1
Sleep Dysfunction 1 1
Sepsis 1 1
No Code Available 1 1
Head Injury 1 1
Abrasion 1 1
Edema 1 1
Cramp(s) /Muscle Spasm(s) 1 1
No Known Impact Or Consequence To Patient 1 1
Thrombosis/Thrombus 1 1
Muscle Spasm(s) 1 1
Joint Swelling 1 1
Insufficient Information 1 1
Fall 1 1
Swelling/ Edema 1 1
No Consequences Or Impact To Patient 1 1
Unspecified Vascular Problem 1 1
Spinal Cord Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Argo Medical Technologies Ltd II May-11-2021
2 Argo Medical Technologies Ltd II Mar-09-2018
3 WANDERCRAFT SAS II May-08-2025
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