FDA.reportPublic FDA data

Flowpresso Compression Device

Primary DI
09413000135374
Brand
Flowpresso Compression Device
Company
MEDELLA HEALTH LIMITED
Model
LCD10
Device description
The Flowpresso Device combines heat and compression therapy. Flowpresso is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy are indicated.
Published
2025-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IRPMassager, Powered Inflatable Tube
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRPMassager, Powered Inflatable TubePhysical Medicine2
IRTPad, Heating, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223729000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223729000FLOWpressoMedella Health Limited2023-12-21IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09413000135374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09413000135374094130001353749413000135374

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent 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 intermittently applying pressure to a patient's arms or legs to promote venous blood flow at timed intervals. This is achieved through the cyclical inflation and deflation of a single-chambered stocking, sleeve, or suit applied to the extremities. The system typically consists of a compression pump, control and timing mechanism, tubing, and pneumatic stocking(s) or suit.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity33 Degrees Fahrenheit122 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+64221913672steve@flowpressousa.com

Regulatory Flags#

DUNS number
671444392
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

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00812120005311Game Ready* Shoulder Sleeve, Medium, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005328Game Ready* Shoulder Sleeve, Large, RightAvanos Medical, Inc.IRP2026-07-31
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