Besmed Various Models of TENS, BE-550/BE-660
FDA 510(k) K031374 · Besmed Health Business Corp
510(k) numberK031374
Submission
- Device name
- Besmed Various Models of TENS, BE-550/BE-660
- Applicant
- Besmed Health Business Corp
Hsin Chu City, TW - Received
- April 30, 2003
- Decision date
- November 28, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K241339 | Besmed Bacterial Filter and HMEFCAH · Traditional | 11/14/2024SE |
| K172804 | Besmed Peak Flow MeterBZH · Traditional | 01/11/2018SE |
| K160112 | Besmed PEEP ValveBYE · Traditional | 04/29/2016SE |
| K150591 | Besmed Reusable Jet NebulizerCAF · Traditional | 06/30/2015SE |
| K143150 | CO2 monitoring line with and without in-line filterCCK · Traditional | 02/05/2015SE |
| K141355 | Volumetric Incentive SpirometerBWF · Traditional | 09/03/2014SE |
| K140370 | Disposable Pressure ManometerCAP · Traditional | 06/19/2014SE |
| K133873 | Triball Incentive SpirometerBWF · Traditional | 04/04/2014SE |
| K091272 | Besmed Jet Nebulizer Bottle SetCAF · Traditional | 11/10/2009SE |
| K031375 | Besmed Various Models of Powered Muscle Stimulator, BE-560/BE-580IPF · Traditional | 11/20/2003SE |
Questions and answers
When was Besmed Various Models of TENS, BE-550/BE-660 cleared by the FDA?
Besmed Various Models of TENS, BE-550/BE-660 (K031374) received a 510(k) decision of Substantially Equivalent on November 28, 2003, 212 days after the submission was received.
What is the product code of K031374?
The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.