The following data is part of a premarket notification filed by Eletromed, Inc. with the FDA for Electromed Reusable Neurostimulation Electrodes.
| Device ID | K030800 |
| 510k Number | K030800 |
| Device Name: | ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES |
| Classification | Electrode, Cutaneous |
| Applicant | ELETROMED, INC. 4938 HAMDEN LN. #750 Betheda, MD 20814 |
| Contact | Lydia Baynes |
| Correspondent | Lydia Baynes ELETROMED, INC. 4938 HAMDEN LN. #750 Betheda, MD 20814 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-13 |
| Decision Date | 2003-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00867991000231 | K030800 | 000 |
| 00867991000224 | K030800 | 000 |
| 00867991000217 | K030800 | 000 |
| 00867991000200 | K030800 | 000 |