Company · CN
Fuji Dynamics Limited
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2016. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 12, 2016 | K161055 | Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ Fuji Dynamics , Ltd., CN | KPI |
| Jan 22, 2016 | K152676 | FD TENS 2090, FD TENS 2095 Fuji Dynamics , Ltd., CN | GZJ |
| Jan 13, 2016 | K152374 | LL TENS 160A, LL TENS 160B Fuji Dynamics , Ltd., CN | NUH |
| Mar 1, 2012 | K111654 | FD TENS 2070 Fuji Dynamics , Ltd., CN | GZJ |
| Nov 9, 2011 | K111645 | FD TENS 2050 OR SLIDE TENS MODEL FD2050 Fuji Dynamics , Ltd., CN | GZJ |
| Jan 7, 2010 | K092780 | INF 4160 PLUS, MODEL D-FJ31F Fuji Dynamics Limited, CN | LIH |
| Dec 13, 2007 | K063642 | FD EMS, MODEL # D-FJ30E Fuji Dynamics Limited, CN | IPF |
| Jan 25, 2006 | K052813 | FD TENS 2030, MODEL DFJ24T Fuji Dynamics Limited, HK | GZJ |
| Feb 11, 2005 | K043407 | INF 4160, MODEL D-FJ27F Fuji Dynamics Limited, CN | LIH |
| May 20, 2004 | K041164 | L-TENS Fuji Dynamics Limited, CN | GZJ |
| Jul 6, 2000 | K994266 | FDTENS 2010 Fuji Dynamics Limited, HK | GZJ |
| Jul 6, 2000 | K994265 | MEDISANA DIGITAL TENS Fuji Dynamics Limited, HK | GZJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||