PlasmaFlight
Massager, Powered Inflatable Tube
ManaMed, Inc.
The following data is part of a premarket notification filed by Manamed, Inc. with the FDA for Plasmaflight.
Pre-market Notification Details
| Device ID | K200351 |
| 510k Number | K200351 |
| Device Name: | PlasmaFlight |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | ManaMed, Inc. 5240 W. Charleston Blvd Las Vegas, NV 89146 |
| Contact | Trevor Theriot |
| Correspondent | Bill Quanqin Dai JKH USA, LLC 14271 Jeffrey Rd. #246 Irvine, CA 92620 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-12 |
| Decision Date | 2020-08-05 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850998008294 | K200351 | 000 |
Trademark Results [PlasmaFlight]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PLASMAFLIGHT 86936954 5210509 Live/Registered |
ManaMed, Inc. 2016-03-11 |
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