REGAIN STAND-UP WHEELCHAIR

Wheelchair, Standup

REGAIN, INC.

The following data is part of a premarket notification filed by Regain, Inc. with the FDA for Regain Stand-up Wheelchair.

Pre-market Notification Details

Device IDK946110
510k NumberK946110
Device Name:REGAIN STAND-UP WHEELCHAIR
ClassificationWheelchair, Standup
Applicant REGAIN, INC. 5577 VANTAGE POINT Columbia,  MD  21044
ContactMichael H Galumbeck
CorrespondentMichael H Galumbeck
REGAIN, INC. 5577 VANTAGE POINT Columbia,  MD  21044
Product CodeIPL  
CFR Regulation Number890.3900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-14
Decision Date1995-02-01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.