The following data is part of a premarket notification filed by The Electrode Store, Inc. with the FDA for Sensory Nerve Electrodes-two Finger Rings, Stimulator Probe Electrodes-facial, Mono, Bi- & Tripolar Nerve Stimulators.
| Device ID | K083758 |
| 510k Number | K083758 |
| Device Name: | SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS |
| Classification | Electrode, Cutaneous |
| Applicant | THE ELECTRODE STORE, INC. 1530 HOLCOMB STREET Port Townsend, WA 98368 |
| Contact | Carl Youngmann |
| Correspondent | Carl Youngmann THE ELECTRODE STORE, INC. 1530 HOLCOMB STREET Port Townsend, WA 98368 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-17 |
| Decision Date | 2009-08-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816022022063 | K083758 | 000 |
| 00816022020601 | K083758 | 000 |
| 00816022020441 | K083758 | 000 |
| 00816022020328 | K083758 | 000 |
| 00816022020311 | K083758 | 000 |
| 00816022020304 | K083758 | 000 |