Transcoutaneous Electro-Neuro Stimulator
FDA 510(k) K884972 · Futuremed Div. of Future Impex Corp.
510(k) numberK884972
Submission
- Device name
- Transcoutaneous Electro-Neuro Stimulator
- Applicant
- Futuremed Div. of Future Impex Corp.
Deerpark, NY, US - Received
- November 30, 1988
- Decision date
- July 27, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K232441 | Unipro (K-UNIPRO-US)GZJ · Traditional | Tenscare, Ltd. | 08/30/2024SE |
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| 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 |
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| K901308 | Spiro Analyzer Model ST 250BZG · Traditional | 07/23/1990SE |
| K871421 | Model HL-100 Portable DC Elect. Therapeutic UnitIPF · Traditional | 01/22/1988SE |
| K873817 | Spiro Analyzer ST-300BZG · Traditional | 12/02/1987SE |
| K872044 | Carbon ElectrodeGXY · Traditional | 07/16/1987SE |
| K872045 | Conductivity GelGYB · Traditional | 07/15/1987SE |
| K871913 | Conductivity GelGYB · Traditional | 07/15/1987SE |
Questions and answers
When was Transcoutaneous Electro-Neuro Stimulator cleared by the FDA?
Transcoutaneous Electro-Neuro Stimulator (K884972) received a 510(k) decision of Substantially Equivalent on July 27, 1989, 239 days after the submission was received.
What is the product code of K884972?
The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.