Home / 510(k) Clearances / K091317

510(k) K091317

LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK by Bio-Medical Research, Ltd. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2009
Date Received
May 4, 2009
Clearance Type
Special
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-Medical Research, Ltd.

  • K203513 — SLENDERTONE Evolve Abs, Type 735 (February 10, 2021)
  • DEN170049 — Innovo (November 6, 2018)
  • K180688 — SLENDERTONE CoreFit Abs 8, Type 734 (October 25, 2018)
  • K161974 — SLENDERTONE® Connect Abs, Type 570 (November 1, 2016)
  • K151903 — Slendertone connect Abs (November 6, 2015)
  • K112934 — NEUROTECH RECOVERY (January 20, 2012)
  • K112258 — NEUROTECH PLUS (January 9, 2012)
  • K103031 — BMR FACE (November 10, 2011)
  • K110350 — KNEEHAB XP (August 3, 2011)
  • K102614 — AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40 (June 3, 2011)

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)