The following data is part of a premarket notification filed by Manamed, Inc with the FDA for Manaflow.
| Device ID | K200353 | 
| 510k Number | K200353 | 
| Device Name: | ManaFlow | 
| Classification | Sleeve, Limb, Compressible | 
| 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 | JOW | 
| CFR Regulation Number | 870.5800 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2020-02-13 | 
| Decision Date | 2020-08-06 | 
| Device Identifier | submissionNumber | Supplement | 
|---|---|---|
| 00850998008287 | K200353 | 000 | 
| 00850998008270 | K200353 | 000 | 
| 00850998008898 | K200353 | 000 | 
| 00810113682259 | K200353 | 000 | 
| 00810113681511 | K200353 | 000 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  MANAFLOW  90527646  not registered Live/Pending | Monospace Protocols LLC 2021-02-12 | 
|  MANAFLOW  90052051  not registered Live/Pending | MANAMED INC 2020-07-14 |