FUJI Dynamics Limited
Dongguan Guangdong, CN
FUJI DYNAMICS LIMITED appears in FDA device records in Dongguan Guangdong, CN. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for FUJI Dynamics Limited between 2000 and 2016. The busiest year on record is 2016, with 3. The most recent is 2016, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2016 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K161055 | Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 | KPI | Substantially Equivalent | |
| K152676 | FD TENS 2090, FD TENS 2095 | GZJ | Substantially Equivalent | |
| K152374 | LL TENS 160A, LL TENS 160B | NUH | Substantially Equivalent | |
| K111654 | FD TENS 2070 | GZJ | Substantially Equivalent | |
| K111645 | FD TENS 2050 OR SLIDE TENS MODEL FD2050 | GZJ | Substantially Equivalent | |
| K092780 | INF 4160 PLUS, MODEL D-FJ31F | LIH | Substantially Equivalent | |
| K063642 | FD EMS, MODEL # D-FJ30E | IPF | Substantially Equivalent | |
| K052813 | FD TENS 2030, MODEL DFJ24T | GZJ | Substantially Equivalent | |
| K043407 | INF 4160, MODEL D-FJ27F | LIH | Substantially Equivalent | |
| K041164 | L-TENS | GZJ | Substantially Equivalent | |
| K994266 | FDTENS 2010 | GZJ | Substantially Equivalent | |
| K994265 | MEDISANA DIGITAL TENS | GZJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9615033 | 3005479189 | FUJI DYNAMICS LIMITED | Room 201, 40 Gao Yu South Road, Pin Shan, Tangxia Town, Dongguan Guangdong 523710 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GZQInstrument, Dowel Cutting
- LIHInterferential Current Therapy
- KPIStimulator, Electrical, Non-Implantable, For Incontinence
- NYNStimulator, Electrical, Transcutaneous, For Arthritis
- IPFStimulator, Muscle, Powered
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain