FDA.reportPublic FDA data

PlasmaFlight

Primary DI
00850998008294
Brand
PlasmaFlight
Company
Manamed, Inc.
Model
FLIGHT001
Catalog number
PFLIGHT01
Device description
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.
Published
2020-11-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Single use
true

Product Codes#

Code, Name table
CodeName
IRPMassager, Powered Inflatable Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRPMassager, Powered Inflatable TubePhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200351000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200351000PlasmaFlightManamed, Inc.2020-08-05IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850998008294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850998008294008509980082948509980082940850998008294

GMDN Terms#

Term, Definition table
TermDefinition
Sequential venous compression systemA system used for the noninvasive treatment and prevention of venous disorders and sequelae such as oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE). It functions by applying sequential pressure to a patient's legs to promote venous blood flow. It consists of a compression pump, control/timing mechanism, tubing and has pneumatic stockings, sleeves, or a suit with several chambers that inflate and deflate sequentially in a pattern beginning at the foot or ankle and continuing to chambers around the calf and thigh. In some systems, each chamber reaches the same pressure but at different times, while others apply greater pressure distally which gradually diminishes higher up.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
084042331
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810113688473ManaMed IncManaMed Ultrasound Coupling GelMANAGEL012022-12-31
00810113684154ManaEZ Wrist Left, Extra Large EZW3908L-XLEZW3908L-XL2025-10-17
00810113684161ManaEZ Wrist Left, Extra SmallEZW3908L-XSEZW3908L-XS2025-10-17
00810113684178ManaEZ Wrist Right, Extra Large EZW3908R-XLEZW3908R-XL2025-10-17
00810113684185ManaEZ Wrist Right, Extra SmallEZW3908R-XSEZW3908R-XS2025-10-17
00810113682969"ManaEZ Single Panel Knee Immobilizer 18"""EZIMM01-18EZIMM01-182025-11-25
00810113682976"ManaEZ Single Panel Knee Immobilizer 20"""EZIMM01-20EZIMM01-202025-11-25
00810113682983"ManaEZ Single Panel Knee Immobilizer 24"""EZIMM01-24EZIMM01-242025-11-25
00810113682990"ManaEZ 3 Panel Knee Immobilizer 18"""EZ3PIMM01-18EZ3PIMM01-182025-11-25
00810113683003"ManaEZ 3 Panel Knee Immobilizer 20"""EZ3PIMM01-20EZ3PIMM01-202025-11-25
00810113683010"ManaEZ 3 Panel Knee Immobilizer 24"""EZ3PIMM01-24EZ3PIMM01-242025-11-25
00810113683294"ManaEZ 3 Panel Knee Immobilizer 16"""EZ3PIMM01-16EZ3PIMM01-162025-11-25
00810113682600ManaMed IncManaEZ Ice Wrist EZIWST012022-10-13
00850998008119ManaMedManaEZ Wrist Universal RightEZW3908R2022-06-20
00850998008126ManaMedManaEZ Wrist Universal LeftEZW3908L2022-06-20
00810113683065ManaEZ ROM Ice ShortEZR001-XSMEZR001-XSM2025-10-17
00810113683515ManaEZ Hip Ice CureTechEZHIP01B-CTEZHIP01B-CT2025-10-03
00810113683522ManaEZ ROM Ice CureTechEZR001-CTEZR001-CT2025-10-03
00810113683539ManaEZ Shoulder Ice CureTechEZSHLD-CTEZSHLD-CT2025-10-03
00810113683577ManaEZ Ice Long Duration KneeEZLDIP-KNEZLDIP-KN2025-11-25

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