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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device powered 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 2
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
REWALK ROBOTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
REWALK ROBOTICS LTD.
  SUBSTANTIALLY EQUIVALENT 3
SAMSUNG ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
US BIONICS, INC. (DBA SUITX)
  SUBSTANTIALLY EQUIVALENT 1
WANDERCRAFT SAS
  SUBSTANTIALLY EQUIVALENT 1
  1.  K221859  Atalante

MDR Year MDR Reports MDR Events
2015 1 1
2016 4 4
2017 8 8
2018 21 21
2020 3 3
2021 2 2
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 11 11
Human-Device Interface Problem 7 7
Nonstandard Device 6 6
Fracture 3 3
Patient-Device Incompatibility 2 2
Battery Problem 2 2
Insufficient Information 2 2
Break 2 2
Crack 2 2
Fire 2 2
Collapse 1 1
Detachment Of Device Component 1 1
Unintended Collision 1 1
Self-Activation or Keying 1 1
Unexpected Therapeutic Results 1 1
Improper or Incorrect Procedure or Method 1 1
Component Missing 1 1
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1
Unintended Movement 1 1
Misassembly by Users 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bone Fracture(s) 30 30
Swelling 5 5
Bruise/Contusion 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Edema 1 1
Fall 1 1
Head Injury 1 1
Muscle Spasm(s) 1 1
No Consequences Or Impact To Patient 1 1
Hip Fracture 1 1
Fracture, Arm 1 1
Joint Swelling 1 1
Spinal Cord Injury 1 1
Sleep Dysfunction 1 1
No Known Impact Or Consequence To Patient 1 1
No Code Available 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Swelling/ Edema 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
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