FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Pelvital System
K Number: K200409
·
Decision Jul 10, 2020
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
63
Applicant Total
5
Review Days
142
Basic Information
- Device Name
- Pelvital System
- K Number
- K200409
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1425
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pelvital USA, Inc.
- Date Received
- February 19, 2020
- Decision Date
- July 10, 2020
- 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
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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 |
| K210764 | Flyte | Apr 13, 2021 | Substantially Equivalent |