ENRAF-NONIUS ENDOMED 182 SYSTEM— 510(k) K003744

Name: FDA 510(k) clearance K003744
Creator: U.S. Food and Drug Administration
Published: 2002-02-20

Substantially Equivalent

Henley Healthcare, Inc.

FDA 510(k) clearance K003744 for ENRAF-NONIUS ENDOMED 182 SYSTEM, Substantially Equivalent on 2002-02-20. Applicant: Henley Healthcare, Inc.. Device class: 2.

Clearance details

Applicant: Henley Healthcare, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2000-12-04
Decision date: 2002-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sugar Land, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GZJ

view all

K252712 — STIMPOD NMS460 Nerve Stimulator2026-05-28
K252767 — actiTENS mini2026-01-16
K252236 — CP Relief Wand Rx - TENS/NMES2025-08-15
K232441 — Unipro (K-UNIPRO-US)2024-08-30
K241228 — TENSWave2024-08-27

More clearances from Henley Healthcare, Inc.

view all

K000084 — ENRAF-NONIUS SONOPULS 190 SYSTEM2000-08-04

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