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510(k) K031374

BESMED VARIOUS MODELS OF TENS, BE-550/BE-660 by Besmed Health Business Corp — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2003
Date Received
April 30, 2003
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 Besmed Health Business Corp

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  • K150591 — Besmed Reusable Jet Nebulizer (June 30, 2015)
  • K143150 — CO2 monitoring line with and without in-line filter (February 5, 2015)
  • K140370 — DISPOSABLE PRESSURE MANOMETER (June 19, 2014)
  • K133873 — TRIBALL INCENTIVE SPIROMETER (April 4, 2014)
  • K091272 — BESMED JET NEBULIZER BOTTLE SET (November 10, 2009)
  • K031375 — BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580 (November 20, 2003)

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)