The following data is part of a premarket notification filed by Hi-dow International Inc. with the FDA for Wrap Accessory Electrodes.
| Device ID | K210383 |
| 510k Number | K210383 |
| Device Name: | Wrap Accessory Electrodes |
| Classification | Electrode, Cutaneous |
| Applicant | Hi-Dow International Inc. 2555 Metro Blvd Maryland Heights, MO 63043 |
| Contact | Eric Chen |
| Correspondent | Eric Chen Hi-Dow International Inc. 2555 Metro Blvd Maryland Heights, MO 63043 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-09 |
| Decision Date | 2021-11-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851640007870 | K210383 | 000 |
| 00851640007863 | K210383 | 000 |
| 00851640007672 | K210383 | 000 |
| 00851640007665 | K210383 | 000 |
| 00851640007856 | K210383 | 000 |
| 00851640007849 | K210383 | 000 |
| 00851640007689 | K210383 | 000 |
| 00851640007603 | K210383 | 000 |