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510(k) K912381

LOW BACK STRIP (OR) K-BACK by Katecho, Inc. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1992
Date Received
May 29, 1991
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 Katecho, Inc.

  • K012404 — K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 (October 12, 2001)
  • K010543 — KM-30 TENS ELECTRODE (May 23, 2001)
  • K003228 — K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A (December 14, 2000)
  • K002806 — K-DEFIB/PACE, MODEL KDP-60A (November 21, 2000)
  • K000870 — KM-10 TENS ELECTRODE (November 7, 2000)
  • K993745 — K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80 (February 3, 2000)
  • K991007 — K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60 (August 23, 1999)
  • K981737 — K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60 (December 9, 1998)
  • K954504 — K-DEFIB/PACE PEDIATRIC ELECTRODE (November 17, 1995)
  • K934692 — K-DEFIB/PACE PEDIATRIC ELECTRODE (January 24, 1995)

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)