Smart TENS, Model: D-BC05T
FDA 510(k) K091045 · Body Clock Health Care, Ltd.
510(k) numberK091045
Submission
- Device name
- Smart TENS, Model: D-BC05T
- Applicant
- Body Clock Health Care, Ltd.
London, England, GB - Received
- April 13, 2009
- Decision date
- December 18, 2009
- 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 |
|---|---|---|
| K041359 | Body Clock Stimplus and Stimplus ProGZJ · Traditional | 08/20/2004SE |
| K022849 | Body Clock TENS N' ToneGZJ · Traditional | 05/20/2003SE |
| K021846 | 804SIII; 804W; Libra TENS; 410; S-Tens IIGZJ · Traditional | 11/22/2002SE |
| K022731 | V TENS PlusGZJ · Traditional | 11/14/2002SE |
| K022493 | EMS 400IPF · Traditional | 10/11/2002SE |
| K022076 | First Choice & First Choice PlusGZJ · Traditional | 09/24/2002SE |
Questions and answers
When was Smart TENS, Model: D-BC05T cleared by the FDA?
Smart TENS, Model: D-BC05T (K091045) received a 510(k) decision of Substantially Equivalent on December 18, 2009, 249 days after the submission was received.
What is the product code of K091045?
The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.