Inf 4160 Plus, Model D-FJ31F
FDA 510(k) K092780 · Fuji Dynamics Limited
510(k) numberK092780
Submission
- Device name
- Inf 4160 Plus, Model D-FJ31F
- Applicant
- Fuji Dynamics Limited
Kowloon, Hong Kong, CN - Received
- September 10, 2009
- Decision date
- January 7, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code LIH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231575 | Vecttor VT-300LIH · Abbreviated | Artaflex, Inc. | 02/08/2024SE |
| K202725 | ETD4000LIH · Traditional | Therasigma, LLC | 03/26/2021SE |
| K183692 | Avid IF2LIH · Traditional | Vision Quest Industries Inc./Dba VQ Orthocare | 06/12/2019SE |
| K122944 | Gemore True Sine Interferential StimulatorLIH · Special | Gemore Technology Co, Ltd. | 12/21/2012SE |
| K121662 | Vecttor VT-200LIH · Abbreviated | Alan Neuromedical Technologies, LLC | 11/21/2012SE |
| K110509 | Everyway Interferntial Stimulator, Model IF-908LIH · Traditional | Everyway Medical Instruments Co.,Ltd | 06/20/2011SE |
| K100246 | MAX-IF1000LIH · Traditional | Bio Protech, Inc. | 11/24/2010SE |
| K092763 | If True Sine Interferential Stimulator, WL-2206DLIH · Special | Well-Life Healthcare Limited | 10/08/2009SE |
| K090023 | If Series True Sine Interferential Stimulator, Model: WL-2206B and WL-2106ELIH · Special | Well-Life Healthcare Limited | 01/30/2009SE |
| K070890 | Everlife Interferential Current Therapy, Model IF-100507LIH · Traditional | Everlife Medical Equipment Co., Ltd. | 06/29/2007SE |
More from Everlife Medical Equipment 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 |
| K063642 | FD EMS, Model # D-FJ30EIPF · Traditional | 12/13/2007SE |
| K052813 | FD TENS 2030, Model DFJ24TGZJ · Traditional | 01/25/2006SE |
| 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 Inf 4160 Plus, Model D-FJ31F cleared by the FDA?
Inf 4160 Plus, Model D-FJ31F (K092780) received a 510(k) decision of Substantially Equivalent on January 7, 2010, 119 days after the submission was received.
What is the product code of K092780?
The FDA product code is LIH – Interferential Current Therapy, a Class II (moderate risk) device regulated under 21 CFR 882.5890.