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510(k) K813098

TENS DEVICE by Staodynamics, Inc.

K813098 is an FDA 510(k) premarket notification submitted by Staodynamics, Inc. for the device "TENS DEVICE". The FDA issued a decision of Substantially Equivalent on November 20, 1981. Staodynamics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1981
Date Received
November 3, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • K811345 — INSIGHT (July 10, 1981)
  • K792501 — PLS MINI (February 26, 1980)
  • K792529 — POINT LOCATOR STIMULATOR (February 26, 1980)
  • K800068 — ELECTRICAL MUSCLE STIMULATOR (EMS) (February 5, 1980)
  • K792502 — TENS 4100 (December 18, 1979)
  • K792474 — TENS 4500 (December 13, 1979)

FDA data resources