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510(k) K792501

PLS MINI by Staodynamics, Inc. — Product Code BWJ

K792501 is an FDA 510(k) premarket notification submitted by Staodynamics, Inc. for the device "PLS MINI". The FDA issued a decision of Substantially Equivalent on February 26, 1980. The device falls under product code BWJ (Locator, Acupuncture Point), a Class II device regulated under 21 CFR 880.5580. Staodynamics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1980
Date Received
December 4, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Locator, Acupuncture Point
Device Class
Class II
Regulation Number
880.5580
Review Panel
HO
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)
  • K800068 — ELECTRICAL MUSCLE STIMULATOR (EMS) (February 5, 1980)
  • K792502 — TENS 4100 (December 18, 1979)
  • K792474 — TENS 4500 (December 13, 1979)

Other clearances for product code BWJ

  • K792529 — POINT LOCATOR STIMULATOR (February 26, 1980)
  • K772424 — RYUSEI (May 9, 1978)

FDA data resources