FDA.reportPublic FDA data

RENPHO Air Compression Leg Massager

Primary DI
10810140061208
Brand
RENPHO Air Compression Leg Massager
Company
Joicom Corporation
Model
RP-ALM071C
Published
2023-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K222991000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222991000Air Compression Leg Massager (model: EMK-701)Xiamen Emoka Health Science & Technology Co., Ltd.2023-03-15IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810140061208PackageGS110In Commercial Distribution
00810140061201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081014006120810810140061208
00810140061201008101400612018101400612010810140061201

GMDN Terms#

Term, Definition table
TermDefinition
Multi-chamber venous compression system garment, reusableAn inflatable device in the form of a stocking, sleeve, or suit that is applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the sequential inflation of several chambers. 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. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
033774836
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
00810140063045RENPHO Eye MassagerR-WME062026-05-26
00810140063014RENPHOPUS-R-WMV01-2-BK2026-05-08
00810140063021RENPHOPUS-R-WMG18-BK2026-05-08
00810140063038RENPHOPUS-R-WMG09-GY2026-05-08
00810140063007RENPHOPUS-R-MSC05-BK2026-04-20
00810140062994RENPHOPUS-R-MSC06-BK2026-04-08
00810140062895RENPHOPUS-R-WMF01-WH2026-01-04
00810140062901RENPHOPUS-R-A018-BU-B12026-01-04
10810140062892RENPHOPUS-R-WMF01-WH2026-01-04
10810140062908RENPHOPUS-R-A018-BU-B12026-01-04
00810140062864RENPHOPUS-R-WMF08-BU2025-12-16
10810140062861RENPHOPUS-R-WMF08-BU2025-12-16
00810140062857RENPHOR-WMG242025-12-03
10810140062854RENPHOR-WMG242025-12-03
00810140062840RENPHOR-MSB042025-11-25
10810140062847RENPHOR-MSB042025-11-25
00810140062123RENPHOR-WMG102024-10-16
00810140062826RENPHOPUS-R-WMF09-BK2025-11-05
00810140062819RENPHOES-CS20M2025-10-24
00810140062802RENPHO Massage GunR-WMG152025-10-22

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Primary DI, Brand, Company table
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08809802644885LX9maxDAESUNG MAREF CO.,LTD.IRP2025-11-14
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08809040526776Air Relax Classic Model AR-1.0 ControlUnit OnlyMaxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526783Air Relax Classic Model AR-1.0 Leg Recovery System-Size 2Maxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526790Air Relax Classic Model AR-1.0 Leg Recovery System-Size 3Maxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526806Air Relax Classic Model AR-1.0 Leg Recovery System-Size 4Maxstar Industrial Co.,Ltd.IRP2025-10-01
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