Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
B-TEMIA INC.
  SUBSTANTIALLY EQUIVALENT 1
CYBERDYNE INC.
  SUBSTANTIALLY EQUIVALENT 2
EKSO BIONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
EXOATLET ASIA CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
REWALK ROBOTICS LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
2020 3 3
2021 2 2
2022 2 2
2023 1 1
2024 6 6
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 9 9
Insufficient 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
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) 9 9
No Clinical Signs, Symptoms or Conditions 2 2
Chest Pain 2 2
Swelling 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
Pain 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
-
-