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510(k) K920983

SONOPULS 590 by Henley Intl. — Product Code IMI

K920983 is an FDA 510(k) premarket notification submitted by Henley Intl. for the device "SONOPULS 590". The FDA issued a decision of Substantially Equivalent on March 9, 1993. The device falls under product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5300. Henley Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1993
Date Received
March 2, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5300
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)
  • K922020 — ENDOMED 582 (September 22, 1992)

Other clearances for product code IMI

  • K240788 — Ultrasound Stimulator (June 4, 2025)
  • K230472 — Sonopuls 190 (October 24, 2023)
  • K222098 — ManaSport+ (March 8, 2023)
  • K210284 — ManaSport (April 26, 2022)
  • K202788 — Sonomed IV, Sonomed V (December 23, 2021)
  • K160378 — BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) (August 25, 2017)
  • K161628 — JAS Pulse(TM) Ultrasonic Therapy (November 10, 2016)
  • K160075 — Accent XL (August 17, 2016)
  • K161502 — MC1 Plus (August 16, 2016)
  • K142976 — UltraTENS (August 26, 2015)

FDA data resources