Home / 510(k) Clearances / K112288

510(k) K112288

JIAJIAN TENS by Wuxi Jiajian Medical Instrument Co., Ltd. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2012
Date Received
August 9, 2011
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 Wuxi Jiajian Medical Instrument Co., Ltd.

  • K244030 — Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) (March 28, 2025)
  • K231425 — Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) (March 27, 2024)
  • K222879 — Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) (January 24, 2023)
  • K202861 — Needle Stimulator (August 27, 2021)
  • K202893 — Transcutaneous Electrical Nerve Stimulator (June 18, 2021)
  • K192568 — Jiajian Self-Adhesive Electrode (February 3, 2021)
  • K123958 — JIAJIAN POINTOSELECT DIGITAL (October 28, 2013)
  • K130768 — JIAJIAN CMN STIMULATOR (August 16, 2013)
  • K122812 — JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS (April 11, 2013)
  • K090199 — JIAJIAN ACUPUNCTURE NEEDLE (August 11, 2009)

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)