The Electrode Store, Inc.: FDA clearances and approvals
The Electrode Store, Inc. has 6 FDA 510(k) clearances (first 1995, latest 2009), across 3 product codes in 1 review panel. Median 510(k) review time: 180 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 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 | 3 | 3 |
| GXZ | Electrode, Needle | 2 | 2 |
| IKT | Electrode, Needle, Diagnostic Electromyograph | 1 | 1 |
Review panels
- Neurology (6)
Most recent The Electrode Store, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K083758 | SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS | GXY | 2009-08-14 | 240 |
| K022197 | SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY | GXY | 2002-08-13 | 39 |
| K020910 | SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF | GXZ | 2002-07-19 | 121 |
| K020445 | THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG | GXY | 2002-05-10 | 88 |
| K926094 | PROTECTRODE SYSTEM | GXZ | 1995-12-06 | 1099 |
| K932691 | PROTECTRODE SYSTEMS CONCENTRIC | IKT | 1995-11-16 | 897 |
Recalls
openFDA lists no recalls under a recalling firm named The Electrode Store, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does The Electrode Store, Inc. have?
The Electrode Store, Inc. has 6 FDA 510(k) clearances (first 1995, latest 2009), across 3 product codes in 1 review panel.
How long does FDA take to clear The Electrode Store, Inc.'s 510(k)s?
The median time from FDA receipt to decision across The Electrode Store, Inc.'s cleared 510(k)s is 180 days.
What devices does The Electrode Store, Inc. make?
Its most frequent FDA product codes are GXY (Electrode, Cutaneous, 3); GXZ (Electrode, Needle, 2); IKT (Electrode, Needle, Diagnostic Electromyograph, 1).
Has The Electrode Store, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching The Electrode Store, Inc. Related entities may recall under other names.
Next steps
- See all 6 The Electrode Store, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GXY, The Electrode Store, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.