FDA.reportPublic FDA data

Flexitouch Plus

Primary DI
00816305023824
Brand
Flexitouch Plus
Company
Tactile Systems Technology, Inc.
Model
3L-FL-MW-L
Device description
Full Leg Medium Assembly, Wide, Left
Published
2022-05-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JOWSleeve, Limb, Compressible
PPSSleeve, Head And Neck, Compressible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2
PPSSleeve, Head And Neck, CompressibleCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203178000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203178000Flexitouch Plus SystemTactile Systems Technology, Inc. (Dba Tactile Medical)2020-12-20JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816305023824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816305023824008163050238248163050238240816305023824

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent venous compression system pumpAn electrically-powered device used for the noninvasive treatment and prevention of venous disorders/sequelae. As part of a compression system, the pump provides the connected stocking/sleeve/suit with the necessary pressure to promote venous blood flow. This is achieved through the cyclical inflation and deflation of a single-chambered stocking/sleeve/suit applied to the extremities. It typically consists of a compressor with control/timing mechanism, pressure limiting device, tubing, and connectors. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
146295980
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816305024890AffloVest6100XS2026-05-27
00816305024906AffloVest6200S2026-05-27
00816305024913AffloVest6300M2026-05-27
00816305024920AffloVest6400L2026-05-27
00816305024937AffloVest6500XL2026-05-27
00816305025101AffloVest704268-001704268-0012026-05-27
00816305025248AffloVestWR6100XS2026-05-27
00816305025255AffloVestWR6200S2026-05-27
00816305025262AffloVestWR6300M2026-05-27
00816305025279AffloVestWR6400L2026-05-27
00816305025286AffloVestWR6500XL2026-05-27
00816305025088FlexiTouch Plus704705-001N/A2025-08-11
00816305025095Nimbl703439-001N/A2025-08-11
00816305025064FlexiTouch Plus702610-0012025-07-17
00816305025071NimblDS PL-HL-00-LR2025-07-17
00816305023596Airwear Air Compression WrapAW-SM-01-BK2019-10-18
00816305023602Airwear Air Compression WrapAW-MD-01-BK2019-10-18
00816305023619Airwear Air Compression WrapAW-LG-01-BK2019-10-18
00816305023626Airwear Air Compression WrapAW-XL-01-BK2019-10-18
00816305023633Airwear Air Compression WrapAW-SO-01-WH2019-10-18

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Primary DI, Brand, Company table
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96973521878458BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878465BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878472BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878489BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
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96973521878625BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878632BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878649BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
06976287180367Compression Therapy DeviceGuangzhou Longest Medical Technology Co., Ltd.JOW2026-07-10
00672736141649BREGBREG, INC.JOW2026-06-25
10193489024500MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18
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