510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K930096Substantially Equivalent

No Cross Contam Hydrotherapy Tank Liner

Land and Sky Mfg., Inc., Council Bluffs IA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930096 is the FDA 510(k) clearance record for NO CROSS CONTAM HYDROTHERAPY TANK LINER, a class II device, cleared for Land and Sky Mfg., Inc. on under FDA product code ILJ (Bath, Hydro-Massage). FDA records list one 510(k) clearance for Land and Sky Mfg., Inc. As of , FDA records show no recalls naming K930096.

Clearance record

Decision date
Received
(538 days to decision)
Product code
ILJ Bath, Hydro-Massage
Regulation
21 CFR 890.5100
Device class
Class II
Review panel
Physical Medicine
Applicant
Land and Sky Mfg., Inc. Old Hwy. 6, Council Bluffs IA
510(k) summary
Summary
Third party review
No

Clearances, product code ILJ

Trailing 12 months

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

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