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510(k) K902822

MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICE by Medical Design & Manufacturing Corp. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1990
Date Received
June 27, 1990
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 Medical Design & Manufacturing Corp.

  • K911911 — MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM (March 20, 1992)
  • K914384 — MEDICAL DESIGNS REUSABLE CARBON RUBBER ELECTRODE (November 13, 1991)
  • K911366 — PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE (September 27, 1991)
  • K895604 — SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES (October 13, 1989)
  • K880492 — INTERCEPT T.E.N.S. DEVICE (April 18, 1988)
  • K834138 — HYPO SUTURE (January 27, 1984)
  • K821848 — ASSURE-MALE EXTERNAL INCONTINCE CATHETER (August 10, 1982)
  • K811224 — MINISTIM (June 2, 1981)
  • K810222 — LIMB ORHTOSIS (February 4, 1981)

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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)