The following data is part of a premarket notification filed by Analytica Ltd with the FDA for Pericoach.
| Device ID | K143580 |
| 510k Number | K143580 |
| Device Name: | PeriCoach |
| Classification | Perineometer |
| Applicant | ANALYTICA LTD 320 ADELAIDE STREET Brisbane, AU 4000 |
| Contact | Geoff Daly |
| Correspondent | Tracey Bullivant Brandwood Biomedical 408, 406 Pacific Highway St Leonards, AU 2065 |
| Product Code | HIR |
| CFR Regulation Number | 884.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-18 |
| Decision Date | 2015-03-18 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PERICOACH 79135113 4607665 Live/Registered |
Analytica Limited 2013-07-22 |