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TPLC
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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 Code
PHL
Regulation Number
890.3480
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
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
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
4
4
Battery Problem
2
2
Fire
2
2
Use of Incorrect Control/Treatment Settings
1
1
Unexpected Therapeutic Results
1
1
Fracture
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Bone Fracture(s)
6
6
No Clinical Signs, Symptoms or Conditions
2
2
Swelling
2
2
Sleep Dysfunction
1
1
Sepsis
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Limb Fracture
1
1
Swelling/ Edema
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Argo Medical Technologies Ltd
II
May-11-2021
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