F5

Wheelchair, Powered

PERMOBIL AB

The following data is part of a premarket notification filed by Permobil Ab with the FDA for F5.

Pre-market Notification Details

Device IDK143014
510k NumberK143014
Device Name:F5
ClassificationWheelchair, Powered
Applicant PERMOBIL AB PER UDDENS VAG 20 Timra,  SE 86123
ContactJan Astrom
CorrespondentJan Astrom
PERMOBIL AB PER UDDENS VAG 20 Timra,  SE 86123
Product CodeITI  
CFR Regulation Number890.3860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-20
Decision Date2015-03-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17330818229844 K143014 000

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