Data / Medical devices / United States / The Electrode Store
The Electrode Store: FDA-registered device maker in Buckley, WA, United States, 8 510(k) clearances
The Electrode Store is registered with the FDA (registration 2022388) in Buckley, WA, United States. It lists 9 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 14, 2009. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2022388
- Address
- 159 W Mason Avenue, Buckley, WA, United States, 98321
- Owner or operator
- The Electrode Store (10025712)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- May 1, 2008
- Registered through
- 2026
- Brand names listed
- ADVANCE, ALERA TES, Alera TES ECG Electrodes, Alera TES ECG Electrodes, Multi-Function, DPNCHECK, Dermagard Alcohol Swab, ELECTRODE STORE, Electrode Store Electrode Cable and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Manufacturer | accessdata.fda.gov |
| Device, Intravascular Catheter Securement | KMK | 1 | Manufacturer | accessdata.fda.gov |
| Device, Nerve Conduction Velocity Measurement | JXE | 2 | Manufacturer | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Manufacturer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Electrocardiograph, Multi-Function | MLN | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Needle | GXZ | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Needle, Diagnostic Electromyograph | IKT | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 14, 2009 | K083758 | SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS | GXY | Substantially Equivalent | The Electrode Store, Inc. | accessdata.fda.gov |
| September 29, 2008 | K081871 | UNIVERSAL ELECTRODES | GXY | Substantially Equivalent | Neurometrix, Inc. | accessdata.fda.gov |
| August 12, 2004 | K041320 | MODIFICATION TO NC-STAT | JXE | Substantially Equivalent | Neurometrix, Inc. | accessdata.fda.gov |
| August 13, 2002 | K022197 | SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY | GXY | Substantially Equivalent | The Electrode Store, Inc. | accessdata.fda.gov |
| July 19, 2002 | K020910 | SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF | GXZ | Substantially Equivalent | The Electrode Store, Inc. | accessdata.fda.gov |
| May 10, 2002 | K020445 | THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG | GXY | Substantially Equivalent | The Electrode Store, Inc. | accessdata.fda.gov |
| December 6, 1995 | K926094 | PROTECTRODE SYSTEM | GXZ | Substantially Equivalent | The Electrode Store, Inc. | accessdata.fda.gov |
| November 16, 1995 | K932691 | PROTECTRODE SYSTEMS CONCENTRIC | IKT | Substantially Equivalent | The Electrode Store, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Cable, Electrode
- All makers of Device, Intravascular Catheter Securement
- All makers of Electrode, Cutaneous
- All makers of Electrode, Electrocardiograph, Multi-Function
- All makers of Electrode, Needle
- All makers of Disinfectant, Medical Devices
Updated August 14, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.