ManaFlow

Sleeve, Limb, Compressible

ManaMed, Inc

The following data is part of a premarket notification filed by Manamed, Inc with the FDA for Manaflow.

Pre-market Notification Details

Device IDK200353
510k NumberK200353
Device Name:ManaFlow
ClassificationSleeve, Limb, Compressible
Applicant ManaMed, Inc 5240 W. Charleston Blvd Las Vegas,  NV  89146
ContactTrevor Theriot
CorrespondentBill Quanqin Dai
JKH USA, LLC 14271 Jeffrey Rd. #246 Irvine,  CA  92620
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-13
Decision Date2020-08-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850998008287 K200353 000
00850998008270 K200353 000
00850998008898 K200353 000
00810113682259 K200353 000
00810113681511 K200353 000

Trademark Results [ManaFlow]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MANAFLOW
MANAFLOW
90527646 not registered Live/Pending
Monospace Protocols LLC
2021-02-12
MANAFLOW
MANAFLOW
90052051 not registered Live/Pending
MANAMED INC
2020-07-14

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