Explorer Mini

Wheelchair, Standup

Permobil AB

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

Pre-market Notification Details

Device IDK190682
510k NumberK190682
Device Name:Explorer Mini
ClassificationWheelchair, Standup
Applicant Permobil AB Box 120 S-861 23 Timra,  SE
ContactIvan Fernandez
CorrespondentIvan Fernandez
Permobil AB Box 120 S-861 23 Timra,  SE
Product CodeIPL  
CFR Regulation Number890.3900 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyPhysical Medicine
510k Review PanelPhysical Medicine
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-18
Decision Date2020-02-27

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