The following data is part of a premarket notification filed by Inspirstar, Inc. with the FDA for Inspirstar Glove Electrode.
| Device ID | K061343 |
| 510k Number | K061343 |
| Device Name: | INSPIRSTAR GLOVE ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | INSPIRSTAR, INC. 891 N. NAPLES DR. Chandler, AZ 85226 |
| Contact | Ning Wu |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-05-15 |
| Decision Date | 2006-05-31 |
| Summary: | summary |