FDA.reportPublic FDA data

Walgreens

Primary DI
10311917137381
Brand
Walgreens
Company
WALGREEN CO.
Model
243398
Device description
Walgreens Therapeutic Air Compression Leg Massager
Published
2022-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

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
K201645000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201645000Massage Compression BootsJkh USA, LLC2020-09-15IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10311917137381PackageGS112In Commercial Distribution
00311917137384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1031191713738110311917137381
00311917137384003119171373843119171373840311917137384

GMDN Terms#

Term, Definition table
TermDefinition
Sequential 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 sequential inflation and deflation of the multi-chambered stocking/sleeve/suit applied to the extremities. It typically consists of a compressor with advanced 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

Contacts#

Phone, Email table
PhoneEmail
1-800-925-4733consumerrelations.pq@walgreens.com

Regulatory Flags#

DUNS number
008965063
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00311917034218Walgreens7654302023-07-11
00311917034249Walgreens7654262023-07-11
00311917077932Walgreens7394332026-10-14
00311917090498Walgreens4172342026-10-12
00311917088556Walgreens3119170885562026-09-30
00311917086521Walgreens1439332026-09-28
00311917156064WALGREENS2576322020-07-22
00311917080062Walgreens7610162026-08-26
00311917086569Walgreens1666772026-08-21
00311917086590Walgreens1666372026-08-21
00311917122045Walgreens5052882023-03-09
00311917158952Walgreens276743WRX2767432020-07-14
00311917014876Walgreens6772599288502016-12-20
00311917048130Walgreens6548789288562016-12-20
00311917014920Walgreens6772579288522016-12-20
00311917025360Walgreens6545679288572016-12-20
00311917048154Walgreens6548829288582016-12-20
00311917085685Walgreens7208802026-05-08
00311917085692Walgreens7208932026-05-08
00311917085739Walgreens7208942026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810050289252HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289269HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289276HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289283HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289290HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
00810050289306HYPERICENORMATEC INDUSTRIES LPIRP2026-10-19
06959557201382Air Compression Therapy DeviceSHENZHEN FUTURE ELECTRONIC CO.,LTDIRP2026-10-15
03858894530502ZT Cube - ZC3ZAMAR MEDICAL d.o.o.IRP2026-10-12
03858894530618ZT CLINICZAMAR MEDICAL d.o.o.IRP2026-10-12
06976331781397AnacondafightwearHuizhou XINYI Technology Co., LTDIRP2026-10-12
06959557201375Air Compression Therapy DeviceSHENZHEN FUTURE ELECTRONIC CO.,LTDIRP2026-10-10
06959557200286Powered Inflatable Tube MassagerSHENZHEN FUTURE ELECTRONIC CO.,LTDIRP2026-09-30
06974000130033HealthpalXiamen Healthpal Electronic Co., Ltd.IRP2026-08-26
00812120004895Game Ready* SystemAvanos Medical, Inc.IRP2026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, MediumAvanos Medical, Inc.IRP2026-07-31
00812120005113Game Ready* Ankle Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005120Game Ready* Ankle Wrap, Extra LargeAvanos Medical, Inc.IRP2026-07-31
00812120005137Game Ready* Shoulder Wrap, Medium, RightAvanos Medical, Inc.IRP2026-07-31
00812120005144Game Ready* Shoulder Wrap, Medium, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005151Game Ready* Shoulder Wrap, Large, RightAvanos Medical, Inc.IRP2026-07-31
00812120005168Game Ready* Shoulder Wrap, Large, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005175Game Ready* Back WrapAvanos Medical, Inc.IRP2026-07-31
00812120005182Game Ready* C-T Spine Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005199Game Ready* Hip/Groin Wrap, RightAvanos Medical, Inc.IRP2026-07-31
00812120005205Game Ready* Hip/Groin Wrap, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005212Game Ready* Hand/Wrist WrapAvanos Medical, Inc.IRP2026-07-31
00812120005229Game Ready* Flexed Elbow WrapAvanos Medical, Inc.IRP2026-07-31
00812120005236Game Ready* Half Leg Boot WrapAvanos Medical, Inc.IRP2026-07-31
00812120005243Game Ready* Full Leg Boot Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005250Game Ready* Straight Knee SleeveAvanos Medical, Inc.IRP2026-07-31