FDA.reportPublic FDA data

ALPHAMED

Primary DI
16953825908390
Brand
ALPHAMED
Company
Shenzhen Urion Technology Co., Ltd
Model
UM605
Catalog number
Yes
Published
2024-07-20
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
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16953825908390PackageGS118In Commercial Distribution
06953825908393PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695382590839016953825908390
06953825908393069538259083936953825908393

GMDN Terms#

Term, Definition table
TermDefinition
Wearable electric massagerAn electrically-powered device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It is typically in the form of a wearable wrap containing vibrating nodes that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment; it may additionally provide heat. This is a home-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421294358
Device count
1
DM exempt
false
Premarket exempt
true
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
06953825911072N/AU81Z2026-05-11
06953825911089HUMHEALTHU81CH2026-05-11
06953825911010N/AU80B2026-04-08
06953825911027N/AU82Y2026-04-08
06953825910983lyobU86Y2026-03-20
16953825910980lyobU86Y2026-03-20
06953825910969N/AU83Z2026-03-17
16953825910966N/AU83Z2026-03-17
06953825910952N/AU81X2026-03-09
16953825910959N/AU81X2026-03-09
06953825910914medisanaBU 6302026-03-03
06953825910907SDUNWU80Z2026-02-16
16953825910904SDUNWU80Z2026-02-16
06953825910846N/AU82V2026-02-06
06953825910853medisanaU83X2026-02-06
16953825910843N/AU82V2026-02-06
16953825910850medisanaU83X2026-02-06
06953825910822SAKERU90B2026-01-23
16953825910829SAKERU90B2026-01-23
06953825910761AlphagoMedU60GH2026-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16973368290059MedisanaZhangzhou Easepal Medical Science And Technology Co., Ltd.ISA2026-04-30
07630039101855MASTERPULS®Storz Medical AGISA2026-04-15
00045915831424Human TouchHuman Touch, LLCISA2026-01-12
00045915831431Human TouchHuman Touch, LLCISA2026-01-12
00045915831448Human TouchHuman Touch, LLCISA2026-01-12
00045915831455Human TouchHuman Touch, LLCISA2026-01-12
00045915831462Human TouchHuman Touch, LLCISA2026-01-12
00045915831479Human TouchHuman Touch, LLCISA2026-01-12
00045915831486Human TouchHuman Touch, LLCISA2026-01-12
00045915831493Human TouchHuman Touch, LLCISA2026-01-12
08034108512679Plus HandpieceDEKA M.E.L.A. SRLISA2025-10-22
00197344153605MEDLINEMEDLINE INDUSTRIES, INC.ISA2025-10-17
08800205600003NeuclareDeepsonbio Co., LtdISA2025-08-08
08809643652087CERAGEM Master V9CERAGEM Co., Ltd.ISA2025-07-15
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