Flyte
FDA 510(k) clearance K210764 · decided 2021-04-13
Clearance details
- K-number
- K210764
- Device name
- Flyte
- Applicant
- Pelvital USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-03-15
- Decision date
- 2021-04-13
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- HIR
- Device class
- 2
- Regulation number
- 884.1425
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Pelvic Floor Exerciser (PF01) (K252748) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2026-04-27 |
| Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) (K240805) | Pelvital USA, Inc. | 2024-08-01 |
| Vaginal Tactile Ultrasound Imager (K231875) | Advanced Tactile Imaging, Inc. | 2024-02-22 |
| Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) (K233362) | Pelvital USA, Inc. | 2023-12-29 |
| Perifit Care+ (K231780) | X6 Innovations | 2023-12-20 |
| Perifit (K221476) | X6 Innovations | 2023-02-10 |
| leva Pelvic Health System (K213913) | Renovia, Inc. | 2022-06-30 |
| Flyte (K212655) | Pelvital USA, Inc. | 2021-09-21 |
| Leva Pelvic Health System (K212495) | Renovia, Inc. | 2021-09-08 |
| Intimate Rose Kegel Exercise System (K193364) | Plus EV Holdings Dba Intimate Rose | 2020-08-24 |
| Pelvital System (K200409) | Pelvital USA, Inc. | 2020-07-10 |
| LEva Pelvic Digital Health System (K192270) | Renovia, Inc. | 2019-11-22 |
Recalls involving this device
No recalls on record reference this clearance.