FD TENS 2030, Model DFJ24T
FDA 510(k) K052813 · Fuji Dynamics Limited
510(k) numberK052813
Submission
- Device name
- FD TENS 2030, Model DFJ24T
- Applicant
- Fuji Dynamics Limited
Kowloon, HK - Received
- October 4, 2005
- Decision date
- January 25, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K252712 | STIMPOD NMS460 Nerve StimulatorGZJ · Traditional | Algiamed Technologies USA, Inc. | 05/28/2026SE |
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| K232441 | Unipro (K-UNIPRO-US)GZJ · Traditional | Tenscare, Ltd. | 08/30/2024SE |
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| 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 |
|---|---|---|
| K161055 | Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji 01/ 02/ 03/ 04/ 05/ 06/…KPI · Traditional | 07/12/2016SE |
| K152676 | FD TENS 2090, FD TENS 2095GZJ · Traditional | 01/22/2016SE |
| K152374 | LL TENS 160A, LL TENS 160BNUH · Traditional | 01/13/2016SE |
| K111654 | FD TENS 2070GZJ · Traditional | 03/01/2012SE |
| K111645 | FD TENS 2050 or Slide TENS Model FD2050GZJ · Traditional | 11/09/2011SE |
| K092780 | Inf 4160 Plus, Model D-FJ31FLIH · Traditional | 01/07/2010SE |
| K063642 | FD EMS, Model # D-FJ30EIPF · Traditional | 12/13/2007SE |
| K043407 | Inf 4160, Model D-FJ27FLIH · Traditional | 02/11/2005SE |
| K041164 | L-TensGZJ · Traditional | 05/20/2004SE |
| K994266 | Fdtens 2010GZJ · Traditional | 07/06/2000SE |
Questions and answers
When was FD TENS 2030, Model DFJ24T cleared by the FDA?
FD TENS 2030, Model DFJ24T (K052813) received a 510(k) decision of Substantially Equivalent on January 25, 2006, 113 days after the submission was received.
What is the product code of K052813?
The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.