510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K881862Substantially Equivalent

Thermo-Body-Wrap System

Thermo Body Wrap Systems, Inc., Clearwater FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881862 is the FDA 510(k) clearance record for THERMO-BODY-WRAP SYSTEM, a class II device, cleared for Thermo Body Wrap Systems, Inc. on under FDA product code IRT (Pad, Heating, Powered). FDA records list one 510(k) clearance for Thermo Body Wrap Systems, Inc. As of , FDA records show no recalls naming K881862.

Clearance record

Decision date
Received
(163 days to decision)
Product code
IRT Pad, Heating, Powered
Regulation
21 CFR 890.5740
Device class
Class II
Review panel
Physical Medicine
Applicant
Thermo Body Wrap Systems, Inc. 4161 114th Ter. #, Clearwater FL
Third party review
No

Clearances, product code IRT

Trailing 12 months

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

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