NEUROTECH PLUS— 510(k) K112258

Substantially Equivalent

Bio-Medical Research, Ltd.

FDA 510(k) clearance K112258 for NEUROTECH PLUS, Substantially Equivalent on 2012-01-09. Applicant: Bio-Medical Research, Ltd.. Device class: 2.

Clearance details

Applicant: Bio-Medical Research, Ltd.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2011-08-05
Decision date: 2012-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

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 Bio-Medical Research, Ltd.

K203513 — SLENDERTONE Evolve Abs, Type 7352021-02-10
DEN170049 — Innovo2018-11-06
K180688 — SLENDERTONE CoreFit Abs 8, Type 7342018-10-25
K161974 — SLENDERTONE® Connect Abs, Type 5702016-11-01
K151903 — Slendertone connect Abs2015-11-06

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