Axelgaard Mfg. Co., Ltd.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Axelgaard Mfg. Co., Ltd.” (first 1985, latest 2014), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 87 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 | 1 | 99 |
| 2014 | 1 | 192 |
| 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 |
|---|---|---|---|
| GXY | Electrode, Cutaneous | 8 | 8 |
| DRX | Electrode, Electrocardiograph | 1 | 1 |
| EGJ | Device, Iontophoresis, Other Uses | 1 | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
Review panels
- Neurology (9)
- Cardiovascular (1)
- Physical Medicine (1)
Most recent Axelgaard Mfg. Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K132422 | PALS PLATINUM NEUROSTIMULATION ELECTRODES | GXY | 2014-02-13 | 192 |
| K130987 | VALUTRODE NEUROSTIMLATION ELECTRODES | GXY | 2013-07-17 | 99 |
| K080580 | COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D | EGJ | 2008-06-18 | 107 |
| K013532 | ULTRASTIM KIT | GZJ | 2002-08-22 | 309 |
| K000947 | ULTRASTIM ELECTRODE, MODEL US4040 | GXY | 2000-06-16 | 85 |
| K000206 | PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 | DRX | 2000-04-13 | 83 |
| K983741 | EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020 | GXY | 1998-12-18 | 57 |
| K970426 | VALUETRODE | GXY | 1997-05-09 | 94 |
| K874469 | TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS) | GXY | 1988-01-28 | 87 |
| K872976 | TENS PALS PLUS | GXY | 1987-09-22 | 54 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Axelgaard Mfg. 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Axelgaard Mfg. Co., Ltd.?
FDA lists 11 510(k) clearances under the applicant name “Axelgaard Mfg. Co., Ltd.” (first 1985, latest 2014), 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 Axelgaard Mfg. Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Axelgaard Mfg. Co., Ltd. is 87 days.
Which FDA product codes appear under Axelgaard Mfg. Co., Ltd.?
The most frequent FDA product codes under this applicant name are GXY (Electrode, Cutaneous, 8); DRX (Electrode, Electrocardiograph, 1); EGJ (Device, Iontophoresis, Other Uses, 1).
Next steps
- See all 11 Axelgaard Mfg. Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GXY, Axelgaard Mfg. 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.