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510(k) K130987

VALUTRODE NEUROSTIMLATION ELECTRODES by Axelgaard Mfg. Co., Ltd. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2013
Date Received
April 9, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type

Other clearances by Axelgaard Mfg. Co., Ltd.

  • K132422 — PALS PLATINUM NEUROSTIMULATION ELECTRODES (February 13, 2014)
  • K080580 — COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MO (June 18, 2008)
  • K013532 — ULTRASTIM KIT (August 22, 2002)
  • 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)

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