Leva Pelvic Health System
Perineometer
Renovia Inc.
The following data is part of a premarket notification filed by Renovia Inc. with the FDA for Leva Pelvic Health System.
Pre-market Notification Details
| Device ID | K213913 |
| 510k Number | K213913 |
| Device Name: | Leva Pelvic Health System |
| Classification | Perineometer |
| Applicant | Renovia Inc. 263 Summer St, 5th Floor Boston, MA 02210 |
| Contact | Jim O'Connor |
| Correspondent | Jacqueline Schmainda Bold Type 2100 N Alafaya Trail Orlando, FL 32826 |
| Product Code | HIR |
| CFR Regulation Number | 884.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-15 |
| Decision Date | 2022-06-30 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860002994406 | K213913 | 000 |
Trademark Results [Leva Pelvic Health System]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LEVA PELVIC HEALTH SYSTEM 97507762 not registered Live/Pending |
Renovia Inc. 2022-07-18 |
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