PlasmaFlight

GUDID 00850998008294

The PlasmaFlight is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue with the hands by use of inflatable pressure cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains.

MANAMED INC

Sequential venous compression system Sequential venous compression system Sequential venous compression system Sequential venous compression system
Primary Device ID00850998008294
NIH Device Record Key6ce6e0fe-bb8a-4458-b254-2f97f4e3778e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlasmaFlight
Version Model NumberFLIGHT001
Company DUNS084042331
Company NameMANAMED INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850998008294 [Primary]
GS100850998008294 [Primary]
GS100850998008294 [Primary]
GS100850998008294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IRPMassager, Powered Inflatable Tube
IRPMassager, Powered Inflatable Tube
IRPMassager, Powered Inflatable Tube
IRPMassager, Powered Inflatable Tube

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-10
Device Publish Date2020-11-02

Devices Manufactured by MANAMED INC

00850998008270 - ManaFlow512020-11-10 Compressible Limb Sleeve Device, Pneumatic compressor, segmental home model without calibrated gradient pressure
00850998008287 - ManaFlow522020-11-10 Compressible Limb Sleeve Device, Pneumatic compressor, segmental home model without calibrated gradient pressure
00850998008294 - PlasmaFlight2020-11-10The PlasmaFlight is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue with the hands by use of inflatable pressure cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains.
00850998008294 - PlasmaFlight2020-11-10 The PlasmaFlight is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massag
00850998008034 - ManaFlexx2019-10-23 ManaFlexx is the only NMES device designed for ease of use by eliminating wires or standalone electrodes. This device is single
B402PF00011E - PlasmaFlow2018-03-29 The PlasmaFlow, model PF0001, is intended to be an easy to use portable system, prescribed by a physician, for use in the home o
00850998008003 - PlasmaFlow2018-03-29 The PlasmaFlow is intended to be an easy to use sequential compression system, prescribed by a physician, for use in the home or
00850998008010 - PlasmaFlow Elite2018-03-29 The PlasmaFlow ELITE is intended to be an easy to use sequential compression system, prescribed by a physician, for use in the h
00850998008027 - Circul82018-03-29 The Circul8 is intended to be an easy to use sequential compression system, prescribed by a physician, for use in the home or cl

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