Axelgaard Mfg. Co., Ltd.
Fallbrook, CA, US
AXELGAARD MFG. CO., LTD. appears in FDA device records in Fallbrook, CA. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Axelgaard Mfg. Co., Ltd. between 1985 and 2014. The busiest year on record is 2000, with 2. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1987 | 1 |
| 1988 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 2000 | 2 |
| 2002 | 1 |
| 2008 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K132422 | PALS PLATINUM NEUROSTIMULATION ELECTRODES | GXY | Substantially Equivalent | |
| K130987 | VALUTRODE NEUROSTIMLATION ELECTRODES | GXY | Substantially Equivalent | |
| K080580 | COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D | EGJ | Substantially Equivalent | |
| K013532 | ULTRASTIM KIT | GZJ | Substantially Equivalent | |
| K000947 | ULTRASTIM ELECTRODE, MODEL US4040 | GXY | Substantially Equivalent | |
| K000206 | PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 | DRX | Substantially Equivalent | |
| K983741 | EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020 | GXY | Substantially Equivalent | |
| K970426 | VALUETRODE | GXY | Substantially Equivalent | |
| K874469 | TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS) | GXY | Substantially Equivalent | |
| K872976 | TENS PALS PLUS | GXY | Substantially Equivalent | |
| K852267 | ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES | GXY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2025066 | 1000603528 | AXELGAARD MFG. CO., LTD. | 520 INDUSTRIAL WAY, FALLBROOK, CA 92028 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Axelgaard Mfg. Co., Ltd. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain