FDA.reportPublic FDA data

N/A

Primary DI
06953825911676
Brand
N/A
Company
Shenzhen Urion Technology Co., Ltd
Model
UM605
Published
2026-07-24
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

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
K250046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250046000Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)Shenzhen Urion Technology Co., Ltd.2025-04-25IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16953825911673PackageGS118In Commercial Distribution
06953825911676PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695382591167316953825911673
06953825911676069538259116766953825911676

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic massagerAn pneumatically-powered device with a vibrating head mechanism which is typically held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head or pads may be interchangeable with others of different size and shape. It can be used for respiratory and physiotherapy treatment, typically in a hospital or institution, but is also suitable for home-use.

Regulatory Flags#

DUNS number
421294358
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
06953825911645N/AU90B Pro2026-07-24
06953825911652ANOVATORU8072026-07-24
06953825911669SPASTACISEU90B Pro2026-07-24
06953825911638ZKZOUFR1022026-07-23
06953825911515N/AU90B Pro2026-07-16
06953825911416N/AU86E2026-07-13
06953825911294N/AU16H2026-07-09
06953825911300N/AU82Z2026-07-09
06953825911317AlphamedU19M2026-07-09
06953825911355N/AU90B Pro2026-07-09
06953825911393N/AU16P2026-07-09
06953825911041ELERAU82V2026-06-03
06953825911188sakerplusU90B2026-06-03
06953825911218AlphamedU90B2026-06-03
06953825911225AlphamedU90B2026-06-03
06953825911232AlphamedU16P2026-06-03
06953825911249KPMNU90BPro2026-06-03
06953825911072N/AU81Z2026-05-11
06953825911089HUMHEALTHU81CH2026-05-11
06953825911010N/AU80B2026-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850087597081Recovery+ Go Compression UnitWMI ENTERPRISES, LLCIRP2026-07-23
06973641880444Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880512Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880680Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880765Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880772Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880789Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880796Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880802Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880819Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
06973641880826Dr. AktiveChengdu Cryo-push Medical Technology Co.,Ltd.IRP2026-07-21
00840397513352Sharper ImageMerchsource, LLCIRP2026-06-28
08809040526691AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809040526707AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809040526714AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809040526721AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
00860015634924POWERPRESS UNITNEO MEDICIRP2026-03-31
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