510(k) K212495
- Device
- Leva Pelvic Health System
- Applicant
- Renovia Inc.
- 510(k) number
- K212495
- Product code
- HIR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-09-08
- Date received
- 2021-08-09
- Regulation
- 884.1425
- Classification name
- Perineometer
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jim O'Connor
- Address
- 263 Summer St., 5th Floor Boston MA US 02210 02210
FDA Registration Numbers#
- 3006636961
- 3013426279
- 3038641388
- 3006317264
- 3004727093
- 3009466220
- 3014657561
- 3021815
- 3030927592
- 3038319740
- 3005210579
- 3010972758
- 3007962592
- 3011630465
- 3014166044
- 1224842
- 9680487
- 3026585193
- 3011905669
- 3031976597
- 1317927
- 9616877
- 3006850006
- 3017230582
- 3011278898
- 3017448360
- 9617486
Source Documents#
Other 510(k) Records For Product Code HIR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252748 | Pelvic Floor Exerciser (PF01) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2026-04-27 |
| K240805 | Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) | Pelvital USA, Inc. | 2024-08-01 |
| K231875 | Vaginal Tactile Ultrasound Imager | Advanced Tactile Imaging, Inc. | 2024-02-22 |
| K233362 | Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) | Pelvital USA, Inc. | 2023-12-29 |
| K231780 | Perifit Care+ | X6 Innovations | 2023-12-20 |
| K221476 | Perifit | X6 Innovations | 2023-02-10 |
| K213913 | leva Pelvic Health System | Renovia, Inc. | 2022-06-30 |
| K212655 | Flyte | Pelvital USA, Inc. | 2021-09-21 |
| K210764 | Flyte | Pelvital USA, Inc. | 2021-04-13 |
| K193364 | Intimate Rose Kegel Exercise System | Plus EV Holdings Dba Intimate Rose | 2020-08-24 |
| K200409 | Pelvital System | Pelvital USA, Inc. | 2020-07-10 |
| K192270 | LEva Pelvic Digital Health System | Renovia, Inc. | 2019-11-22 |
| K180637 | leva Pelvic Floor Trainer | Renovia, Inc. | 2018-04-04 |
| K171896 | Feminine Personal Trainer (FPT) | Ralston Group | 2017-08-29 |
| K162689 | Vibrance Pelvic Trainer | Bioinfinity (M) Sdn. Bhd. | 2017-06-08 |
Legacy Summary#
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FDA Review#
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