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510(k) K010209

ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL by Biomedical Life Systems, Inc. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2001
Date Received
January 23, 2001
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 Biomedical Life Systems, Inc.

  • K172971 — BMLS16-1 (July 8, 2018)
  • K102051 — PAIN BUDDY (July 29, 2011)
  • K061476 — ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1 (July 26, 2006)
  • K042711 — MODEL BMLS03-7 (March 14, 2005)
  • K041388 — COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, (November 23, 2004)
  • K040007 — INTERFERENTIAL STIMULATOR, MODEL BMLS02-6 (July 7, 2004)
  • K033174 — BMLS03-3 (June 30, 2004)
  • K040824 — INTERFERENTIAL STIMULATOR, MODEL BMLS03-6 (April 29, 2004)
  • K040306 — HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-7 (March 23, 2004)
  • K033455 — ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5 (January 15, 2004)

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)