Home / 510(k) Clearances / K850004

510(k) K850004

TRANSCUTANEOUS NERVE STIMULATOR FOR PAIN RELIEF by Todd Medical, Inc. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1985
Date Received
January 2, 1985
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 Todd Medical, Inc.

  • K873288 — CLOSED FOLEY CATHETER SYSTEM (November 27, 1987)
  • K873499 — TODD MEDICAL/SKILLED CARE PRODUCTS (November 24, 1987)
  • K873287 — IRRIGATION TRAY (W/120CC OF STERILE NORMAL SALINE) (November 13, 1987)
  • K873469 — TODD MEDICAL/SKILLED CARE PRODUCTS (October 29, 1987)
  • K850646 — ECLIPSE SELF ADHERING ELECTRODE (September 3, 1985)

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)