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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
B-TEMIA INC.
  SUBSTANTIALLY EQUIVALENT 1
CYBERDYNE INC.
  SUBSTANTIALLY EQUIVALENT 1
EKSO BIONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
EXOATLET ASIA CO. LTD.
  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 2

MDR Year MDR Reports MDR Events
2020 3 3
2021 2 2
2022 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Fire 2 2
Battery Problem 2 2
Use of Incorrect Control/Treatment Settings 1 1
Fracture 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bone Fracture(s) 5 5
No Clinical Signs, Symptoms or Conditions 2 2
Swelling 2 2
Sleep Dysfunction 1 1
Limb Fracture 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Swelling/ Edema 1 1
Sepsis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Argo Medical Technologies Ltd II May-11-2021
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