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510(k) K202186

TrueRelief Device by Truerelief — Product Code GZJ

K202186 is an FDA 510(k) premarket notification submitted by Truerelief for the device "TrueRelief Device". The FDA issued a decision of Substantially Equivalent on March 23, 2021. 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
March 23, 2021
Date Received
August 4, 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

  • K252712 — STIMPOD NMS460 Nerve Stimulator (May 28, 2026)
  • 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