FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Flyte
K Number: K210764
·
Decision Apr 13, 2021
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
64
Applicant Total
5
Review Days
29
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Basic Information
- Device Name
- Flyte
- K Number
- K210764
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 884.1425
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pelvital USA, Inc.
- Date Received
- March 15, 2021
- Decision Date
- April 13, 2021
- Product Code
- HIR
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HIR | Perineometer | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIR), ordered by most recent decision date.
Pelvic Floor Exerciser (PF01)
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Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)
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Vaginal Tactile Ultrasound Imager
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Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)
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Perifit Care+
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Perifit
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Pelvital USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240805 | Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) | Aug 1, 2024 | Substantially Equivalent |
| K233362 | Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) | Dec 29, 2023 | Substantially Equivalent |
| K212655 | Flyte | Sep 21, 2021 | Substantially Equivalent |
| K200409 | Pelvital System | Jul 10, 2020 | Substantially Equivalent |