K-DISPERSE— 510(k) K921679

Substantially Equivalent

Katecho, Inc.

FDA 510(k) clearance K921679 for K-DISPERSE, Substantially Equivalent on 1992-10-06. Applicant: Katecho, Inc.. Device class: 2.

Clearance details

Applicant: Katecho, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1992-04-08
Decision date: 1992-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Moines, IA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GZJ

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 Katecho, Inc.

K012404 — K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-852001-10-12
K010543 — KM-30 TENS ELECTRODE2001-05-23
K003228 — K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A2000-12-14
K002806 — K-DEFIB/PACE, MODEL KDP-60A2000-11-21
K000870 — KM-10 TENS ELECTRODE2000-11-07

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