PURECARE AT-903 T.E.N.S.— 510(k) K931715

Name: FDA 510(k) clearance K931715
Creator: U.S. Food and Drug Administration
Published: 1994-01-27

Substantially Equivalent

Fuching Enterprise Co., Ltd.

FDA 510(k) clearance K931715 for PURECARE AT-903 T.E.N.S., Substantially Equivalent on 1994-01-27. Applicant: Fuching Enterprise Co., Ltd.. Device class: 2.

Clearance details

Applicant: Fuching Enterprise Co., Ltd.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1993-04-06
Decision date: 1994-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, 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

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