510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K852637Substantially Equivalent

Thermo Trim

Suntec Health & Fitness Group, Inc., Westport CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852637 is the FDA 510(k) clearance record for THERMO TRIM, a class II device, cleared for Suntec Health & Fitness Group, Inc. on under FDA product code IRT (Pad, Heating, Powered). FDA records list 2 510(k) clearances for Suntec Health & Fitness Group, Inc., from to . As of , FDA records show no recalls naming K852637.

Clearance record

Decision date
Received
(153 days to decision)
Product code
IRT Pad, Heating, Powered
Regulation
21 CFR 890.5740
Device class
Class II
Review panel
Physical Medicine
Applicant
Suntec Health & Fitness Group, Inc. P.O. Box 2668, Westport CT
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