ODFS Pace XL

Stimulator, Neuromuscular, External Functional

Odstock Medical Ltd

The following data is part of a premarket notification filed by Odstock Medical Ltd with the FDA for Odfs Pace Xl.

Pre-market Notification Details

Device IDK171396
510k NumberK171396
Device Name:ODFS Pace XL
ClassificationStimulator, Neuromuscular, External Functional
Applicant Odstock Medical Ltd Salisbury District Hospital Salisbury,  GB Sp2 8bj
ContactSteven Crook
CorrespondentSteven Crook
Odstock Medical Ltd Salisbury District Hospital Salisbury,  GB Sp2 8bj
Product CodeGZI  
CFR Regulation Number882.5810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-11
Decision Date2018-01-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060195470441 K171396 000

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