Fuji Dynamics Limited: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Fuji Dynamics Limited” (first 2000, latest 2010), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 119 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 4 | 4 |
| LIH | Interferential Current Therapy | 2 | 2 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
Review panels
- Neurology (6)
- Physical Medicine (1)
Most recent Fuji Dynamics Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K092780 | INF 4160 PLUS, MODEL D-FJ31F | LIH | 2010-01-07 | 119 |
| K063642 | FD EMS, MODEL # D-FJ30E | IPF | 2007-12-13 | 371 |
| K052813 | FD TENS 2030, MODEL DFJ24T | GZJ | 2006-01-25 | 113 |
| K043407 | INF 4160, MODEL D-FJ27F | LIH | 2005-02-11 | 63 |
| K041164 | L-TENS | GZJ | 2004-05-20 | 17 |
| K994266 | FDTENS 2010 | GZJ | 2000-07-06 | 202 |
| K994265 | MEDISANA DIGITAL TENS | GZJ | 2000-07-06 | 202 |
Recalls
openFDA lists no recalls under a recalling firm named Fuji Dynamics Limited.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Fuji Dynamics , Ltd. (5 510(k)s)
- Fuji Systems Corp. (3 510(k)s)
- Fuji Film Medical Systems (1 510(k)s)
- Fuji Optical Systems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fuji Dynamics Limited?
FDA lists 7 510(k) clearances under the applicant name “Fuji Dynamics Limited” (first 2000, latest 2010), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Fuji Dynamics Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fuji Dynamics Limited is 119 days.
Which FDA product codes appear under Fuji Dynamics Limited?
The most frequent FDA product codes under this applicant name are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 4); LIH (Interferential Current Therapy, 2); IPF (Stimulator, Muscle, Powered, 1).
Next steps
- See all 7 Fuji Dynamics Limited clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Fuji Dynamics Limited's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.