FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)
K Number: K233362
·
Decision Dec 29, 2023
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
64
Applicant Total
5
Review Days
88
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Basic Information
- Device Name
- Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)
- K Number
- K233362
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 884.1425
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pelvital USA, Inc.
- Date Received
- October 2, 2023
- Decision Date
- December 29, 2023
- 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 |
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