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510(k) K896817

MODEL T11 FLUIDOTHERAPY UNIT by Henley Intl. — Product Code LSB

K896817 is an FDA 510(k) premarket notification submitted by Henley Intl. for the device "MODEL T11 FLUIDOTHERAPY UNIT". The FDA issued a decision of Substantially Equivalent on January 18, 1991. The device falls under product code LSB (Unit, Fluidotherapy), a Class II device regulated under 21 CFR 890.5100. Henley Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1991
Date Received
December 4, 1989
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 by Henley Intl.

  • K943449 — NEUROLOGICAL DIAGNOSTIC DEVICES (November 15, 1995)
  • K926279 — UPPER BODY EXERCISER (May 5, 1994)
  • K926278 — STAIR CLIMBER (May 5, 1994)
  • K926287 — EXERCISE BICYCLE (March 22, 1994)
  • K926314 — HYDRA FITNESS MODEL 311 TOTAL POWER (March 18, 1994)
  • K926313 — COMPUTERIZED TESTING AND EXERCISE SYSTEMS (February 4, 1994)
  • K915864 — MONOTRODE CUTANEOUS ELECTRODE (July 21, 1993)
  • K922036 — SONOPULS 591 (June 29, 1993)
  • K926316 — TRUE-TRAC, STRATUS (March 24, 1993)
  • K920983 — SONOPULS 590 (March 9, 1993)

Other clearances for product code LSB

  • K011768 — THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202 (August 3, 2001)
  • K011243 — CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000 (July 6, 2001)
  • K871802 — MODEL K210 AND K211 FLUIDOTHERAPY UNITS (September 4, 1987)

FDA data resources