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510(k) K850855

TENS GB1001 DEVICE by Medicon, Inc. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1986
Date Received
March 1, 1985
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 Medicon, Inc.

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  • K844702 — GAUZE ASORBABLE (April 1, 1985)
  • K844573 — ABSORBABLE GAUZE PRODUCTS (March 5, 1985)
  • K844574 — WHEELCHAIRS (February 21, 1985)
  • K844703 — GOWNS, SURGICAL (January 10, 1985)
  • K844704 — CAPS (O.R. NURSE, SURGICAL) (January 10, 1985)
  • K844705 — SHOE COVERS (January 10, 1985)
  • K840034 — VACUUM STRETCHER IMMOBILIZER (February 27, 1984)

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  • K212618 — iRelieve Microcurrent Pain Relief System (September 14, 2022)
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  • K220578 — Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) (May 25, 2022)
  • K220503 — TENS device-EmeTerm 2, Model: YF-ZTY-E2 (April 23, 2022)