The following data is part of a premarket notification filed by Plus Ev Holdings Dba Intimate Rose with the FDA for Intimate Rose Kegel Exercise System.
| Device ID | K193364 |
| 510k Number | K193364 |
| Device Name: | Intimate Rose Kegel Exercise System |
| Classification | Perineometer |
| Applicant | Plus EV Holdings Dba Intimate Rose 1700 Iron St. North Kansas City, MO 64116 |
| Contact | Aaron Wilt |
| Correspondent | Elizabeth Proctor Q-Metrics LLC 860 Lindenwood Lane Medina, OH 44256 |
| Product Code | HIR |
| CFR Regulation Number | 884.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-04 |
| Decision Date | 2020-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850005838135 | K193364 | 000 |