F3

Wheelchair, Powered

PERMOBIL AB

The following data is part of a premarket notification filed by Permobil Ab with the FDA for F3.

Pre-market Notification Details

Device IDK143180
510k NumberK143180
Device Name:F3
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 Received2014-11-04
Decision Date2015-03-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17330818676433 K143180 000

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