MAGBODY DT-600— 510(k) K053284

Substantially Equivalent

Durtech System Corp.

FDA 510(k) clearance K053284 for MAGBODY DT-600, Substantially Equivalent on 2006-03-10. Applicant: Durtech System Corp.. Device class: 2.

Clearance details

Applicant: Durtech System Corp.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2005-11-25
Decision date: 2006-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: His-Chih Taipei, TW

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 Durtech System Corp.

K053285 — MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM2006-01-05

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