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510(k) K013532

ULTRASTIM KIT by Axelgaard Mfg. Co., Ltd. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2002
Date Received
October 17, 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 Axelgaard Mfg. Co., Ltd.

  • K132422 — PALS PLATINUM NEUROSTIMULATION ELECTRODES (February 13, 2014)
  • K130987 — VALUTRODE NEUROSTIMLATION ELECTRODES (July 17, 2013)
  • K080580 — COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MO (June 18, 2008)
  • K000947 — ULTRASTIM ELECTRODE, MODEL US4040 (June 16, 2000)
  • K000206 — PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 (April 13, 2000)
  • K983741 — EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020 (December 18, 1998)
  • K970426 — VALUETRODE (May 9, 1997)
  • K874469 — TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS) (January 28, 1988)
  • K872976 — TENS PALS PLUS (September 22, 1987)
  • K852267 — ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES (June 18, 1985)

Other clearances for product code GZJ

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  • 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)