The following data is part of a premarket notification filed by Milex Products, Inc. with the FDA for Milex Kegel Perineal Exerciser.
| Device ID | K862410 |
| 510k Number | K862410 |
| Device Name: | MILEX KEGEL PERINEAL EXERCISER |
| Classification | Perineometer |
| Applicant | MILEX PRODUCTS, INC. 5915 NORTHWEST HIGHWAY Chicago, IL 60631 |
| Contact | Robert Shaw |
| Correspondent | Robert Shaw MILEX PRODUCTS, INC. 5915 NORTHWEST HIGHWAY Chicago, IL 60631 |
| Product Code | HIR |
| CFR Regulation Number | 884.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-25 |
| Decision Date | 1986-07-31 |