510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K923173Substantially Equivalent

Obalon Cover

Turnsoft, Inc., Huntersville NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923173 is the FDA 510(k) clearance record for OBALON COVER, a class I device, cleared for Turnsoft, Inc. on under FDA product code FMW (Cover, Mattress (Medical Purposes)). FDA records list 2 510(k) clearances for Turnsoft, Inc., from to . As of , FDA records show no recalls naming K923173.

Clearance record

Decision date
Received
(129 days to decision)
Product code
FMW Cover, Mattress (Medical Purposes)
Regulation
21 CFR 880.6190
Device class
Class I
Review panel
General Hospital
Applicant
Turnsoft, Inc. 13420 W. Reese Blvd., Huntersville NC
510(k) summary
Statement
Third party review
No

Clearances, product code FMW

Trailing 12 months

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

FDA records show no clearances under product code FMW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FMW, 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