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510(k) K800068

ELECTRICAL MUSCLE STIMULATOR (EMS) by Staodynamics, Inc. — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1980
Date Received
January 11, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

Other clearances by Staodynamics, Inc.

  • K852298 — TENS-AID STERILE ELECTRODES FOR POST-OP TENS (June 24, 1985)
  • K843964 — TENS-AID PREMIUM ELECTRODES (February 25, 1985)
  • K832988 — STAODYN EMS/PLUS (November 22, 1983)
  • K813283 — 10D (TENS DEVICE) (February 10, 1982)
  • K813098 — TENS DEVICE (November 20, 1981)
  • K811345 — INSIGHT (July 10, 1981)
  • K792529 — POINT LOCATOR STIMULATOR (February 26, 1980)
  • K792501 — PLS MINI (February 26, 1980)
  • K792502 — TENS 4100 (December 18, 1979)
  • K792474 — TENS 4500 (December 13, 1979)

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