The following data is part of a premarket notification filed by Regulatory Insight, Inc. with the FDA for Kegel Smart, Kegelsmart Pearl.
| Device ID | K140780 |
| 510k Number | K140780 |
| Device Name: | KEGEL SMART, KEGELSMART PEARL |
| Classification | Perineometer |
| Applicant | REGULATORY INSIGHT, INC. 33 Golden Eagle Lane Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls REGULATORY INSIGHT, INC. 33 Golden Eagle Lane Littleton, CO 80127 |
| Product Code | HIR |
| CFR Regulation Number | 884.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-28 |
| Decision Date | 2014-09-10 |
| Summary: | summary |