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510(k) K841400

NEURO PULSE by Parker Laboratories, Inc. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1984
Date Received
April 3, 1984
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

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  • K864556 — AQUALUBE(TM) (December 1, 1986)
  • K861239 — ACRYLIC SOLDER (April 17, 1986)
  • K855167 — DYNA SYSTEM (March 4, 1986)
  • K851895 — POLYGEL ULTRASOUND GEL (September 27, 1985)
  • K852956 — CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION (August 9, 1985)
  • K840548 — RESIL (April 17, 1984)
  • K831039 — COMPLUS VARIOUS FORMS (May 27, 1983)

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  • K220578 — Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) (May 25, 2022)
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