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510(k) K922036

SONOPULS 591 by Henley Intl. — Product Code IMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1993
Date Received
May 1, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5860
Review Panel
PM
Submission Type

Other clearances by Henley Intl.

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  • 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)
  • K926316 — TRUE-TRAC, STRATUS (March 24, 1993)
  • K920983 — SONOPULS 590 (March 9, 1993)
  • K922020 — ENDOMED 582 (September 22, 1992)

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