The following data is part of a premarket notification filed by Inspirstar, Inc. with the FDA for Inspirstar Is02 Microcurrent Stimulator.
| Device ID | K060368 |
| 510k Number | K060368 |
| Device Name: | INSPIRSTAR IS02 MICROCURRENT STIMULATOR |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| 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 | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-02-13 |
| Decision Date | 2006-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B524IS02PRO0 | K060368 | 000 |
| B524IS02LCD0 | K060368 | 000 |
| B524IS02BA0 | K060368 | 000 |
| B524IS02PROS0 | K060368 | 000 |
| B524IS02LCDS0 | K060368 | 000 |
| B524IS02BAS0 | K060368 | 000 |