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
K943162Substantially Equivalent

Lake Stagezero(tm) Air Flotation Bed

Lake Medical Products, Inc., North Brunswick NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943162 is the FDA 510(k) clearance record for LAKE STAGEZERO(TM) AIR FLOTATION BED, a class II device, cleared for Lake Medical Products, Inc. on under FDA product code FNM (Mattress, Air Flotation, Alternating Pressure). FDA records list 15 510(k) clearances for Lake Medical Products, Inc., from to . As of , FDA records show no recalls naming K943162.

Clearance record

Decision date
Received
(241 days to decision)
Product code
FNM Mattress, Air Flotation, Alternating Pressure
Regulation
21 CFR 880.5550
Device class
Class II
Review panel
General Hospital
Applicant
Lake Medical Products, Inc. 1588 Rte. 130, Suite C-2, North Brunswick NJ
510(k) summary
Summary
Third party review
No

Clearances, product code FNM

Trailing 12 months

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

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