8 results
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43ms
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Sources: EU EUDAMED, US FDA
Motek Medical B.V.
Manufacturer
🇳🇱 Netherlands
MOTEK MEDICAL B.V.
FDA registration
MOTEK MEDICAL B.V.·3 products·🇳🇱 Netherlands
BODY WEIGHT SUPPORT LIGHT
FDA Adverse Event
Malfunction
·MOTEK MEDICAL B.V.·Product code BXB·August 1, 2023
BODY WEIGHT SUPPORT LIGHT
FDA Adverse Event
Malfunction
·MOTEK MEDICAL B.V.·Product code BXB·April 23, 2019
C-MILL
FDA Adverse Event
Injury
·MOTEK MEDICAL B.V.·Product code IOL·January 21, 2022
Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait - Product Usage: is designed to facilitate functional gait training of subjects with gait and/or balance impairment by providing dynamic partial vertical unloading during walking on a treadmill. The device will be used as an assistive device for gait deficiency rehabilitation and research purposes.
FDA Enforcement
Class II
·Ongoing·MOTEK MEDICAL B.V.·June 3, 2020
Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait - Product Usage: is designed to facilitate functional gait training of subjects with gait and/or balance impairment by providing dynamic partial vertical unloading during walking on a treadmill. The device will be used as an assistive device for gait deficiency rehabilitation and research purposes.
FDA Recall
Open, Classified
·MOTEK MEDICAL B.V. Hogehilweg 18 18 Unit C Amsterdam Netherlands·Product code BXB·July 29, 2019
Motek Medical B.V.
Importer
🇳🇱 Netherlands