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510(k) K041164

L-TENS by Fuji Dynamics Limited — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2004
Date Received
May 3, 2004
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 Fuji Dynamics Limited

  • K092780 — INF 4160 PLUS, MODEL D-FJ31F (January 7, 2010)
  • K063642 — FD EMS, MODEL # D-FJ30E (December 13, 2007)
  • K052813 — FD TENS 2030, MODEL DFJ24T (January 25, 2006)
  • K043407 — INF 4160, MODEL D-FJ27F (February 11, 2005)
  • K994266 — FDTENS 2010 (July 6, 2000)
  • K994265 — MEDISANA DIGITAL TENS (July 6, 2000)

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)