SONOPULS 590— 510(k) K920983

Substantially Equivalent

Henley Intl.

FDA 510(k) clearance K920983 for SONOPULS 590, Substantially Equivalent on 1993-03-09. Applicant: Henley Intl.. Device class: 2.

Clearance details

Applicant: Henley Intl.
Product code: Code IMI
Device class: Class 2
Regulation: 21 CFR 890.5300
Advisory panel: Physical Medicine
Date received: 1992-03-02
Decision date: 1993-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sugar Land, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IMI

K240788 — Ultrasound Stimulator2025-06-04
K230472 — Sonopuls 1902023-10-24
K222098 — ManaSport+2023-03-08
K210284 — ManaSport2022-04-26
K202788 — Sonomed IV, Sonomed V2021-12-23

More clearances from Henley Intl.

K943449 — NEUROLOGICAL DIAGNOSTIC DEVICES1995-11-15
K926278 — STAIR CLIMBER1994-05-05
K926279 — UPPER BODY EXERCISER1994-05-05
K926287 — EXERCISE BICYCLE1994-03-22
K926314 — HYDRA FITNESS MODEL 311 TOTAL POWER1994-03-18

Data sourced from openFDA. This site is unofficial and independent of the FDA.