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510(k) K011768

THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202 by Thermo-Electric Co. — Product Code LSB

K011768 is an FDA 510(k) premarket notification submitted by Thermo-Electric Co. for the device "THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202". The FDA issued a decision of Substantially Equivalent on August 3, 2001. The device falls under product code LSB (Unit, Fluidotherapy), a Class II device regulated under 21 CFR 890.5100.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2001
Date Received
June 7, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Fluidotherapy
Device Class
Class II
Regulation Number
890.5100
Review Panel
PM
Submission Type

Other clearances for product code LSB

  • K011243 — CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000 (July 6, 2001)
  • K896817 — MODEL T11 FLUIDOTHERAPY UNIT (January 18, 1991)
  • K871802 — MODEL K210 AND K211 FLUIDOTHERAPY UNITS (September 4, 1987)

FDA data resources