FDA.reportPublic FDA data

FLOWELL

Primary DI
06971234470249
Brand
FLOWELL
Company
Xiamen Weiyou Intelligent Technology Co.,Ltd
Model
FW-IPC06T
Published
2024-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K210967000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210967000Air Pressure Therapy System: VU-IPC06Xiamen Weiyou Intelligent Technology Co., Ltd.2021-05-11IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971234470249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971234470249069712344702496971234470249

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding electric massagerAn electrically-powered benchtop, mobile, or stationary device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It may be in the form of a vibrating bed or a tabletop/freestanding unit with a massaging handpiece or other interchangeable mechanisms that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment; it may additionally provide heat. This device is intended for use in healthcare facilities and is not applicable to home therapies.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
549592185
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971234471178VUVU-IPC04B2026-05-06
06971234470447FORCE XCX52025-07-15
06971234470379FLOWELLFLOWELL-IPC06T2025-05-13
06971234470386FLOWELLFLOWELL-IPC042025-05-13
06971234470393FLOWELLFLOWELL-IPC06T2025-05-13
06971234470201FLOWELLFW-IPC4M2024-11-04
06971234470218FLOWELLFW-IPC4M2024-11-04
06971234470225FLOWELLFW-IPC06T2024-11-04
36971234470202FLOWELLFW-IPC4M2024-11-04
36971234470219FLOWELLFW-IPC4M2024-11-04
36971234470226FLOWELLFW-IPC06T2024-11-04
36971234470240FLOWELLFW-IPC06T2024-11-04
06971234479266VUVU-IPC032021-11-29
06971234479273VUVU-NIPC022021-11-29
06971234479280VUVU-IPC042021-11-29
06971234479297VUVU-IPC062021-11-29
06971234479303VUVU-IPC04B2021-11-29
06971234479327VUVU-IPC05B2021-11-29
06971234479334VUVU-AMP022021-11-29
06971234479341VUVU-AMP012021-11-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809040526707AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809040526714AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809040526721AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809802644885LX9maxDAESUNG MAREF CO.,LTD.IRP2025-11-14
08809802644892LX9maxDAESUNG MAREF CO.,LTD.IRP2025-11-14
08809802644908LX9maxDAESUNG MAREF CO.,LTD.IRP2025-11-14
08809802644915LX9maxDAESUNG MAREF CO.,LTD.IRP2025-11-14
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
08809643652087CERAGEM Master V9CERAGEM Co., Ltd.IRP2025-07-15
08809494000686CERAGEM Master V7CERAGEM Co., Ltd.IRP2025-02-12
08809494000983CERAGEM Master V7CERAGEM Co., Ltd.IRP2025-02-12
08809802644526LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644533LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644540LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644557LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644564LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644571LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644588LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644595LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644601LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644618LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644625LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644632LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644649LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644656LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644663LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20