Fuji Dynamics , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Fuji Dynamics , Ltd.” (first 2011, latest 2016), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 145 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 | 1 | 262 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 3 | 126 |
| 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 | 3 | 3 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 1 | 1 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 1 | 1 |
Review panels
Most recent Fuji Dynamics , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161055 | Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 | KPI | 2016-07-12 | 89 |
| K152676 | FD TENS 2090, FD TENS 2095 | GZJ | 2016-01-22 | 126 |
| K152374 | LL TENS 160A, LL TENS 160B | NUH | 2016-01-13 | 145 |
| K111654 | FD TENS 2070 | GZJ | 2012-03-01 | 262 |
| K111645 | FD TENS 2050 OR SLIDE TENS MODEL FD2050 | GZJ | 2011-11-09 | 149 |
Recalls
openFDA lists no recalls under a recalling firm named Fuji Dynamics , Ltd..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Fuji Dynamics , Ltd. (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via KPI)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via KPI)
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 Limited (7 510(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 , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Fuji Dynamics , Ltd.” (first 2011, latest 2016), 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 , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fuji Dynamics , Ltd. is 145 days.
Which FDA product codes appear under Fuji Dynamics , Ltd.?
The most frequent FDA product codes under this applicant name are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 3); KPI (Stimulator, Electrical, Non-Implantable, For Incontinence, 1); NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter, 1).
Next steps
- See all 5 Fuji Dynamics , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Fuji Dynamics , Ltd.'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.