BIO-TENS— 510(k) K844618

Substantially Equivalent

Bio-Research Associates, Inc.

FDA 510(k) clearance K844618 for BIO-TENS, Substantially Equivalent on 1985-08-21. Applicant: Bio-Research Associates, Inc.. Device class: 2.

Clearance details

Applicant: Bio-Research Associates, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1984-11-27
Decision date: 1985-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, 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 Bio-Research Associates, Inc.

K130158 — M-SCAN2013-07-25
K082927 — BIOEMG III2009-02-06
K061799 — QUADRATENS, MODEL QT-422006-08-28
K003176 — BIOEMG II AND BIOJVA2001-01-04
K991756 — 3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE1999-12-10

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