STIMPOD NMS460 Nerve Stimulator
FDA 510(k) K161091 · Xavant Technology (Pty), Ltd.
510(k) numberK161091
Submission
- Device name
- STIMPOD NMS460 Nerve Stimulator
- Applicant
- Xavant Technology (Pty), Ltd.
Silverton, ZA - Received
- April 18, 2016
- Decision date
- January 18, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GZJ
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K213049 | STIMPOD NMS450 Nerve StimulatorBXN · Traditional | 10/16/2022SE |
| K140853 | Stimpod ST2-3010 Nerve StimulatorBXN · Special | 11/06/2014SE |
| K110118 | Stimtrode Single Use Nerve StimulatorBXN · Special | 02/17/2011SE |
| K102084 | Stimpod NMS450 Nerve StimulatorBXN · Traditional | 12/16/2010SE |
| K093591 | Stimpod Model NMS-400 Nerve StimulatorBXN · Traditional | 12/03/2009SE |
| K072092 | Xpod/Xmap Nerve StimulatorBXN · Traditional | 11/15/2007SE |
Questions and answers
When was STIMPOD NMS460 Nerve Stimulator cleared by the FDA?
STIMPOD NMS460 Nerve Stimulator (K161091) received a 510(k) decision of Substantially Equivalent on January 18, 2017, 275 days after the submission was received.
What is the product code of K161091?
The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.