510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K931594Substantially Equivalent

Thera-Turn Cm-1000 Mattress Overlay System

Medical Device Inspection Company, Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931594 is the FDA 510(k) clearance record for THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM, a class II device, cleared for Medical Device Inspection Co., Inc. on under FDA product code IOQ (Bed, Flotation Therapy, Powered). FDA records list 30 510(k) clearances for Medical Device Inspection Co., Inc., from to . As of , FDA records show no recalls naming K931594.

Clearance record

Decision date
Received
(265 days to decision)
Product code
IOQ Bed, Flotation Therapy, Powered
Regulation
21 CFR 890.5170
Device class
Class II
Review panel
Physical Medicine
Applicant
Medical Device Inspection Co., Inc. 55 Northern Blvd., Suite 301, Great Neck NY
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