HT-WEDGE

Lift, Patient, Ac-powered

D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L

The following data is part of a premarket notification filed by D.t. Davis Enterprises Ltd. T/a Hovertech Int'l with the FDA for Ht-wedge.

Pre-market Notification Details

Device IDK121287
510k NumberK121287
Device Name:HT-WEDGE
ClassificationLift, Patient, Ac-powered
Applicant D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L 513 SOUTH CLEWELL STREET Bethlehem,  PA  18015
ContactSusan Pavelko
CorrespondentSusan Pavelko
D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L 513 SOUTH CLEWELL STREET Bethlehem,  PA  18015
Product CodeFNG  
CFR Regulation Number880.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-30
Decision Date2012-10-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816299011388 K121287 000

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