510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970364Substantially Equivalent

Airtec2 Low Air Loss Therapy Bed

Apex Metal, Inc., Mt Pleasant SC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970364 is the FDA 510(k) clearance record for AIRTEC2 LOW AIR LOSS THERAPY BED, a class II device, cleared for Apex Metal, Inc. on under FDA product code IOQ (Bed, Flotation Therapy, Powered). FDA records list 3 510(k) clearances for Apex Metal, Inc., from to . As of , FDA records show no recalls naming K970364.

Clearance record

Decision date
Received
(290 days to decision)
Product code
IOQ Bed, Flotation Therapy, Powered
Regulation
21 CFR 890.5170
Device class
Class II
Review panel
Physical Medicine
Applicant
Apex Metal, Inc. P.O. Box 1026, Mt Pleasant SC
510(k) summary
Statement
Third party review
No

Clearances, product code IOQ

Trailing 12 months

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

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