TX-2(TENS)— 510(k) K874333

Substantially Equivalent

Oms Medico, Inc.

FDA 510(k) clearance K874333 for TX-2(TENS), Substantially Equivalent on 1987-11-20. Applicant: Oms Medico, Inc.. Device class: 2.

Clearance details

Applicant: Oms Medico, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1987-10-22
Decision date: 1987-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Braintree, MA, 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 Oms Medico, Inc.

K874550 — TX-4(TENS) (SIGMA TENS)1987-11-20
K873420 — GLOBALCARE(TENS)1987-10-08
K873484 — 120Z(TENS)1987-09-16
K871699 — TX-3(TENS)1987-06-25
K865063 — UNI-PULS(TENS) MODEL #2921987-03-17

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