Famidoc Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Famidoc Technology Co., Ltd.” (first 2005, latest 2021), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 176 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 | 2 | 349 |
| 2013 | 0 | — |
| 2014 | 1 | 326 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 90 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Famidoc Technology Co., Ltd. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 166 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | 3 | 3 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 1 | 1 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 1 | 1 |
Review panels
- General Hospital (3)
- Physical Medicine (2)
- Neurology (1)
Most recent Famidoc Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212918 | Heat StimPlus | NUH | 2021-12-13 | 90 |
| K130723 | FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL | NGX | 2014-02-07 | 326 |
| K113010 | FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR | IPF | 2012-12-21 | 437 |
| K113761 | INFRARED THERMOMETER | FLL | 2012-09-07 | 261 |
| K072641 | DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4. | FLL | 2007-11-01 | 44 |
| K052849 | INFRARED THERMOMETER, FDIR-V1 | FLL | 2005-10-26 | 15 |
Recalls
openFDA lists no recalls under a recalling firm named Famidoc Technology Co., 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.
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.
- Famidoc Technology Company Limited (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Famidoc Technology Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Famidoc Technology Co., Ltd.” (first 2005, latest 2021), across 4 product codes in 3 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 Famidoc Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Famidoc Technology Co., Ltd. is 176 days.
Which FDA product codes appear under Famidoc Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are FLL (Continuous Measurement Thermometer, 3); IPF (Stimulator, Muscle, Powered, 1); NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 1).
Next steps
- See all 6 Famidoc Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FLL, Famidoc Technology Co., 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.