Neuromuscular Stimulator
FDA 510(k) K932611 · Myo/Kinetic Systems, Inc.
510(k) numberK932611
Submission
- Device name
- Neuromuscular Stimulator
- Applicant
- Myo/Kinetic Systems, Inc.
Menomonee Falls, WI, US - Received
- May 28, 1993
- Decision date
- January 31, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K232441 | Unipro (K-UNIPRO-US)GZJ · Traditional | Tenscare, Ltd. | 08/30/2024SE |
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| K233046 | Electrical Neuromuscular Stimulator, Cure TrioGZJ · Traditional | Oriental Inspiration Limited | 04/19/2024SE |
| 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 |
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| K220578 | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)GZJ · Traditional | Bozhou Rongjian Medical Appliance Co., Ltd. | 05/25/2022SE |
More from Bozhou Rongjian Medical Appliance Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K945937 | TE-800 Pelvic Floor ExerciserHIR · Traditional | 07/14/1995SE |
| K945292 | TS-700P Control XP Electrical StimulatorKPI · Traditional | 04/12/1995SE |
| K944972 | Uro-Gram Cystomrtrogram with UroflowmetryEXY · Traditional | 03/08/1995SE |
| K936041 | Urogram CystometrogramFEN · Traditional | 04/18/1994SE |
| K932764 | Therapeutic Stimulator 300(TS-300) & 300P(TS-300P)IPF · Traditional | 10/01/1993SE |
| K932399 | Therapeutic Stim 200 (TS-200)/200P (TS-200P)IPF · Traditional | 08/11/1993SE |
| K914904 | Therapeutic Stimulator 2100 (TS-2100)IPF · Traditional | 04/28/1992SE |
Questions and answers
When was Neuromuscular Stimulator cleared by the FDA?
Neuromuscular Stimulator (K932611) received a 510(k) decision of Substantially Equivalent on January 31, 1994, 248 days after the submission was received.
What is the product code of K932611?
The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.