FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PlasmaFlight
K Number: K200351
·
Decision Aug 5, 2020
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
152
Applicant Total
7
Review Days
175
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Basic Information
- Device Name
- PlasmaFlight
- K Number
- K200351
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5650
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Manamed, Inc.
- Date Received
- February 12, 2020
- Decision Date
- August 5, 2020
- Product Code
- IRP
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IRP | Massager, Powered Inflatable Tube | FDA class 2 | Physical Medicine |
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Other Clearances by Manamed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K231569 | ManaFlexx 2 (model: MF002-RX, MF002-OTC) | Nov 3, 2023 | Substantially Equivalent |
| K222098 | ManaSport+ | Mar 8, 2023 | Substantially Equivalent |
| K210284 | ManaSport | Apr 26, 2022 | Substantially Equivalent |
| K211253 | PlasmaWave | May 26, 2021 | Substantially Equivalent |
| K200353 | ManaFlow | Aug 6, 2020 | Substantially Equivalent |
| K160318 | PlasmaFlow | Apr 1, 2016 | Substantially Equivalent |