510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011768Substantially Equivalent

Thermo-Therapy, Models Tt-101, Tt-201, and Tt-202

Thermo-Electric Co., Imperial PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011768 is the FDA 510(k) clearance record for THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202, a class II device, cleared for Thermo-Electric Co. on under FDA product code LSB (Unit, Fluidotherapy). FDA records list one 510(k) clearance for Thermo-Electric Co. As of , FDA records show no recalls naming K011768.

Clearance record

Decision date
Received
(57 days to decision)
Product code
LSB Unit, Fluidotherapy
Regulation
21 CFR 890.5100
Device class
Class II
Review panel
Physical Medicine
Applicant
Thermo-Electric Co. 455 Rt. 30, Imperial PA
510(k) summary
Summary
Third party review
No

Clearances, product code LSB

Trailing 12 months

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

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