The following data is part of a premarket notification filed by Bioinfinity (m) Sdn. Bhd. with the FDA for Vibrance Pelvic Trainer.
| Device ID | K162689 |
| 510k Number | K162689 |
| Device Name: | Vibrance Pelvic Trainer |
| Classification | Perineometer |
| Applicant | BIOINFINITY (M) SDN. BHD. NO. 21, JALAN 4/62 A, BANDAR MENJALARA, KEPONG Kepong, MY 52200 |
| Contact | Ng Shea Kang |
| Correspondent | Carrie Hetrick EMERGO GROUP 2500 BEE CAVE ROAD, BUILDING 1, SUITE 300 Austin, TX 78746 |
| Product Code | HIR |
| CFR Regulation Number | 884.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-27 |
| Decision Date | 2017-06-08 |
| Summary: | summary |