Fuji Dynamics Limited
Registered establishment in Dongguan, Guangdong, China. 6 device types, 12 clearances.
Fuji Dynamics Limited is a manufacturer holding a current FDA establishment registration. The registration covers Instrument, Dowel Cutting, Stimulator, Muscle, Powered and 4 other device types. Its earliest product listing with the FDA dates from 2000.
Registration
| Registered name | FUJI DYNAMICS LIMITED |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 9615033 |
| FEI number | 3005479189 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 富士達有限公司 |
|---|---|
| Source | Hong Kong company register lookup |
Location
| City | Dongguan |
|---|---|
| Province | Guangdong |
| Address | Room 201, 40 Gao Yu South Road, Pin Shan, Tangxia Town |
| Postal code | 523710 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Instrument, Dowel Cutting | Class 2 | Fuji Tens III | 2011 | 1 |
| Interferential Current Therapy | Class 2 | INF4160C, IF 4K, INF4160 Plus, INF 4160C, INF4160 | 2007 | 7 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | Class 2 | Empi Phoenix | 2013 | 22 |
| Stimulator, Muscle, Powered | Class 2 | Empi Phoenix, FD EMS, FD Tens 2090 & FD Tens 2095 | 2008 | 33 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | Class 2 | FD Tens 2030, OBI Tens, L-Tens, Senatone, Empi Phoenix, FD Tens 2010 and 2 more | 2000 | 32 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | Class 2 | LL Tens, PR0100, PR0200, Easy Tens Plus | 2017 | 57 |
Clearances
12 clearances name Fuji Dynamics Limited as applicant. 2 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K161055 | 2016-07-12 | KPI | Traditional | This company |
| K152676 | 2016-01-22 | GZJ | Traditional | This company |
| K152374 | 2016-01-13 | NUH | Traditional | This company |
| K111654 | 2012-03-01 | GZJ | Traditional | This company |
| K111645 | 2011-11-09 | GZJ | Traditional | This company |
| K092780 | 2010-01-07 | LIH | Traditional | This company |
| K063642 | 2007-12-13 | IPF | Traditional | This company |
| K052813 | 2006-01-25 | GZJ | Traditional | This company |
| K043407 | 2005-02-11 | LIH | Traditional | This company |
| K041164 | 2004-05-20 | GZJ | Traditional | This company |
| K994265 | 2000-07-06 | GZJ | Traditional | This company |
| K994266 | 2000-07-06 | GZJ | Traditional | This company |
| K124016 | 2013-05-06 | IPF | Abbreviated | DJO, LLC |
| K893874 | 1989-12-22 | GZQ | Traditional | Altoona Medical Supply |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1977 |
|---|---|
| Main products | TENS units, Electro-therapy devices |
| Certifications | FDA cleared |
| Export markets | North America, Europe, Asia |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.