MOBILIMB-CPM UPPER/LOWER LIMB DEVICE

Exerciser, Powered

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Mobilimb-cpm Upper/lower Limb Device.

Pre-market Notification Details

Device IDK823495
510k NumberK823495
Device Name:MOBILIMB-CPM UPPER/LOWER LIMB DEVICE
ClassificationExerciser, Powered
Applicant SYNTHES (USA) 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeBXB  
CFR Regulation Number890.5380 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-11-23
Decision Date1983-01-21

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