Electrical Neuromuscular Stimulator, Cure Trio
FDA 510(k) K233046 · Oriental Inspiration Limited
510(k) numberK233046
Submission
- Device name
- Electrical Neuromuscular Stimulator, Cure Trio
- Applicant
- Oriental Inspiration Limited
Hong Kong, CN - Received
- September 25, 2023
- Decision date
- April 19, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K252712 | STIMPOD NMS460 Nerve StimulatorGZJ · Traditional | Algiamed Technologies USA, Inc. | 05/28/2026SE |
| K252767 | actiTENS miniGZJ · Traditional | Sublimed | 01/16/2026SE |
| K252236 | CP Relief Wand Rx - TENS/NMESGZJ · Special | N & C Holdings, LLC | 08/15/2025SE |
| K232441 | Unipro (K-UNIPRO-US)GZJ · Traditional | Tenscare, Ltd. | 08/30/2024SE |
| K241228 | TENSWaveGZJ · Abbreviated | Zynex Medical Officer | 08/27/2024SE |
| K222879 | Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)GZJ · Traditional | Wuxi Jiajian Medical Instrument Co., Ltd. | 01/24/2023SE |
| K212618 | iRelieve Microcurrent Pain Relief SystemGZJ · Traditional | Fast Track Technologies, Inc. | 09/14/2022SE |
| K213802 | StimOnTM Pain Relief System (GM2439)GZJ · Traditional | Gimer Medical Co., Ltd. | 08/26/2022SE |
| K220578 | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)GZJ · Traditional | Bozhou Rongjian Medical Appliance Co., Ltd. | 05/25/2022SE |
| K220503 | TENS device-EmeTerm 2, Model: YF-ZTY-E2GZJ · Traditional | Wat Medical Technology, Inc. | 04/23/2022SE |
More from Wat Medical Technology, Inc.
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|---|---|---|
| K213133 | Keffort (MC-100, MC-100A)KPI · Traditional | 04/13/2022SE |
| K212285 | Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)NUH · Traditional | 12/22/2021SE |
| K170269 | Hee HR MiniOHT · Traditional | 05/03/2017SE |
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Questions and answers
When was Electrical Neuromuscular Stimulator, Cure Trio cleared by the FDA?
Electrical Neuromuscular Stimulator, Cure Trio (K233046) received a 510(k) decision of Substantially Equivalent on April 19, 2024, 207 days after the submission was received.
What is the product code of K233046?
The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.