Cleared Traditional

THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202

K011768 · Thermo-Electric Co. · Physical Medicine
Aug 2001
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K011768 is an FDA 510(k) clearance for the THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202, a Unit, Fluidotherapy (Class II — Special Controls, product code LSB), submitted by Thermo-Electric Co. (Imperial, US). The FDA issued a Cleared decision on August 3, 2001, 57 days after receiving the submission on June 7, 2001. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5100.

Submission Details

510(k) Number K011768 FDA.gov
FDA Decision Cleared SESE
Date Received June 07, 2001
Decision Date August 03, 2001
Days to Decision 57 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code LSB — Unit, Fluidotherapy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5100