The following data is part of a premarket notification filed by Bioinfinity (m)sdn.bhd. with the FDA for Vibrance Kegel Device (vkd).
| Device ID | K141893 |
| 510k Number | K141893 |
| Device Name: | VIBRANCE KEGEL DEVICE (VKD) |
| Classification | Perineometer |
| Applicant | BIOINFINITY (M)SDN.BHD. 816 CONGRESS AVENUE, SUITE1400 Austin, TX 78701 |
| Contact | Carrie Hetrick |
| Correspondent | Carrie Hetrick BIOINFINITY (M)SDN.BHD. 816 CONGRESS AVENUE, SUITE1400 Austin, TX 78701 |
| Product Code | HIR |
| CFR Regulation Number | 884.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-14 |
| Decision Date | 2014-12-18 |
| Summary: | summary |