BioWaveGO
FDA 510(k) K180943 · Biowave Corporation
510(k) numberK180943
Submission
- Device name
- BioWaveGO
- Applicant
- Biowave Corporation
Norwalk, CT, US - Received
- April 10, 2018
- Decision date
- August 17, 2018
- 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 |
|---|---|---|
| K261522 | BioWave BioWrapsGXY · Special | 06/03/2026SE |
| K203158 | BioWave BioWrapsGXY · Traditional | 07/08/2021SE |
| K210202 | BioWaveGO RXGZJ · Special | 02/24/2021SE |
| K152437 | BiowaveHOME Neuromodulation Pain Therapy DeviceGZJ · Special | 09/25/2015SE |
| K072123 | Homewave Neuromodulations Pain Therapy DeviceGZJ · Traditional | 02/01/2008SE |
| K061166 | Deepwave Percutaneous Neuromodulation Pain Therapy SystemNHI · Traditional | 08/15/2006SE |
| K052289 | Deepwave Neuromodulation Pain Therapy DeviceLIH · Traditional | 12/13/2005SE |
Questions and answers
When was BioWaveGO cleared by the FDA?
BioWaveGO (K180943) received a 510(k) decision of Substantially Equivalent on August 17, 2018, 129 days after the submission was received.
What is the product code of K180943?
The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.