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TPLC
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Device
exerciser, measuring
Product Code
ISD
Regulation Number
890.5360
Device Class
2
Premarket Reviews
Manufacturer
Decision
ERGOLINE GMBH
SUBSTANTIALLY EQUIVALENT
1
LODE B.V.
SUBSTANTIALLY EQUIVALENT
1
PENUMBRA, INC.
SUBSTANTIALLY EQUIVALENT
1
SLEEP MODUS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
1
1
2017
1
1
2018
2
2
2019
1
1
2021
1
1
2023
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Malposition of Device
3
3
Adverse Event Without Identified Device or Use Problem
2
2
Crack
1
1
Defective Component
1
1
Use of Device Problem
1
1
Detachment of Device or Device Component
1
1
Fracture
1
1
Device Operates Differently Than Expected
1
1
Corroded
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Limb Fracture
4
4
No Patient Involvement
2
2
Partial thickness (Second Degree) Burn
2
2
No Known Impact Or Consequence To Patient
1
1
Reaction
1
1
No Consequences Or Impact To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
BTE Technologies, Inc.
II
Jul-06-2015
2
MedX Holdings, Inc.
II
Jan-07-2015
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