Omniprobe Electrical Nerve Stimulator
FDA 510(k) K831147 · Omni Intl., Inc.
510(k) numberK831147
Submission
- Device name
- Omniprobe Electrical Nerve Stimulator
- Applicant
- Omni Intl., Inc.
Walker, MI, US - Received
- April 8, 1983
- Decision date
- July 18, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| 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 |
More from Bozhou Rongjian Medical Appliance Co., Ltd.
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| K853255 | Omnimed I.V. Solution Admin. SetFPA · Traditional | 08/23/1985SE |
| K851938 | Omnimed Surgical GownFYA · Traditional | 06/28/1985SE |
| K851654 | Omnimed ClampHXD · Traditional | 05/31/1985SE |
| K851734 | Omnimed Superior Transducer ProtectorFIB · Traditional | 05/23/1985SE |
| K850706 | F-Series ImplantDZE · Traditional | 04/10/1985SE |
| K850112 | Omnimed IV Solution Administration SetFPA · Traditional | 02/22/1985SE |
| K850066 | Omnimed Nasal Oxygen CannulaCAT · Traditional | 01/24/1985SE |
| K821523 | Omni TENSGZJ · Traditional | 06/16/1982SE |
Questions and answers
When was Omniprobe Electrical Nerve Stimulator cleared by the FDA?
Omniprobe Electrical Nerve Stimulator (K831147) received a 510(k) decision of Substantially Equivalent on July 18, 1983, 101 days after the submission was received.
What is the product code of K831147?
The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.