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510(k) K844618

BIO-TENS by Bio-Research Associates, Inc. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1985
Date Received
November 27, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

Other clearances by Bio-Research Associates, Inc.

  • K130158 — M-SCAN (July 25, 2013)
  • K082927 — BIOEMG III (February 6, 2009)
  • K061799 — QUADRATENS, MODEL QT-42 (August 28, 2006)
  • K003176 — BIOEMG II AND BIOJVA (January 4, 2001)
  • K991756 — 3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE (December 10, 1999)
  • K981563 — BIOPAK MEASUREMENT SYSTEM (September 15, 1998)
  • K952218 — JT-3 ELECTROGNATHOGRAPH (September 21, 1995)
  • K873947 — BIO-EMG MODEL 800 (April 27, 1988)
  • K822565 — NEEDLE CATHETER JEJUNOSTOMY KIT (September 28, 1982)

Other clearances for product code GZJ

  • K252767 — actiTENS mini (January 16, 2026)
  • K252236 — CP Relief Wand Rx - TENS/NMES (August 15, 2025)
  • K232441 — Unipro (K-UNIPRO-US) (August 30, 2024)
  • K241228 — TENSWave (August 27, 2024)
  • K233046 — Electrical Neuromuscular Stimulator, Cure Trio (April 19, 2024)
  • K222879 — Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) (January 24, 2023)
  • K212618 — iRelieve Microcurrent Pain Relief System (September 14, 2022)
  • K213802 — StimOnTM Pain Relief System (GM2439) (August 26, 2022)
  • K220578 — Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) (May 25, 2022)
  • K220503 — TENS device-EmeTerm 2, Model: YF-ZTY-E2 (April 23, 2022)