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510(k) K201431

OGYILI TENS/NMES Stimulator by Gongguan Tutamen Metalwork Co., Ltd. — Product Code GZJ

K201431 is an FDA 510(k) premarket notification submitted by Gongguan Tutamen Metalwork Co., Ltd. for the device "OGYILI TENS/NMES Stimulator". The FDA issued a decision of Substantially Equivalent on November 9, 2020. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2020
Date Received
June 1, 2020
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 for product code GZJ

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  • 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)

FDA data resources