510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K121287Substantially Equivalent

Ht-Wedge

D.T. Davis Enterprises Ltd. T/A Hovertech Int'L, Bethlehem PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121287 is the FDA 510(k) clearance record for HT-WEDGE, a class II device, cleared for D.T. Davis Enterprises Ltd. T/A Hovertech Int'L on under FDA product code FNG (Lift, Patient, Ac-Powered). FDA records list 2 510(k) clearances for D.T. Davis Enterprises Ltd. T/A Hovertech Int'L, from to . As of , FDA records show no recalls naming K121287.

Clearance record

Decision date
Received
(156 days to decision)
Product code
FNG Lift, Patient, Ac-Powered
Regulation
21 CFR 880.5500
Device class
Class II
Review panel
General Hospital
Applicant
D.T. Davis Enterprises Ltd. T/A Hovertech Int'L 513 S. Clewell St., Bethlehem PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FNG

Trailing 12 months

FDA records hold no clearances under product code FNG in the trailing twelve months.

FDA records show no clearances under product code FNG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FNG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260