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510(k) K811345

INSIGHT by Staodynamics, Inc. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1981
Date Received
May 12, 1981
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 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)
  • 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)

Other clearances for product code GZJ

  • K252767 — actiTENS mini (January 16, 2026)
  • K252236 — CP Relief Wand Rx - TENS/NMES (August 15, 2025)
  • K232441 — Unipro (K-UNIPRO-US) (August 30, 2024)
  • K241228 — TENSWave (August 27, 2024)
  • K233046 — Electrical Neuromuscular Stimulator, Cure Trio (April 19, 2024)
  • K222879 — Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) (January 24, 2023)
  • K212618 — iRelieve Microcurrent Pain Relief System (September 14, 2022)
  • K213802 — StimOnTM Pain Relief System (GM2439) (August 26, 2022)
  • K220578 — Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) (May 25, 2022)
  • K220503 — TENS device-EmeTerm 2, Model: YF-ZTY-E2 (April 23, 2022)