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510(k) K871112

PELTIERTHERAPY(C) HEAT/COLD TREATMENT by Henley Intl. — Product Code IMF

K871112 is an FDA 510(k) premarket notification submitted by Henley Intl. for the device "PELTIERTHERAPY(C) HEAT/COLD TREATMENT". The FDA issued a decision of Substantially Equivalent on May 6, 1987. The device falls under product code IMF (Unit, Chilling), a Class I device regulated under 21 CFR 890.5940. Henley Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1987
Date Received
March 19, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Chilling
Device Class
Class I
Regulation Number
890.5940
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 IMF

  • K900419 — CRYOTRON-UL30 (February 27, 1990)

FDA data resources