Flyte
FDA 510(k) K212655 · Pelvital USA, Inc.
510(k) numberK212655
Submission
- Device name
- Flyte
- Applicant
- Pelvital USA, Inc.
Minneapolis, MN, US - Received
- August 23, 2021
- Decision date
- September 21, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HIR – Perineometer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1425
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HIR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252748 | Pelvic Floor Exerciser (PF01)HIR · Traditional | Hunan Accurate Bio-Medical Technology Co., Ltd. | 04/27/2026SE |
| K240805 | Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)HIR · Traditional | Pelvital USA, Inc. | 08/01/2024SE |
| K231875 | Vaginal Tactile Ultrasound ImagerHIR · Traditional | Advanced Tactile Imaging, Inc. | 02/22/2024SE |
| K233362 | Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)HIR · Special | Pelvital USA, Inc. | 12/29/2023SE |
| K231780 | Perifit Care+HIR · Traditional | X6 Innovations | 12/20/2023SE |
| K221476 | PerifitHIR · Traditional | X6 Innovations | 02/10/2023SE |
| K213913 | leva Pelvic Health SystemHIR · Traditional | Renovia, Inc. | 06/30/2022SE |
| K212495 | Leva Pelvic Health SystemHIR · Special | Renovia, Inc. | 09/08/2021SE |
| K210764 | FlyteHIR · Special | Pelvital USA, Inc. | 04/13/2021SE |
| K193364 | Intimate Rose Kegel Exercise SystemHIR · Traditional | Plus EV Holdings Dba Intimate Rose | 08/24/2020SE |
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Questions and answers
When was Flyte cleared by the FDA?
Flyte (K212655) received a 510(k) decision of Substantially Equivalent on September 21, 2021, 29 days after the submission was received.
What is the product code of K212655?
The FDA product code is HIR – Perineometer, a Class II (moderate risk) device regulated under 21 CFR 884.1425.