FDA.reportPublic FDA data

Medisana

Primary DI
16973368290059
Brand
Medisana
Company
Zhangzhou Easepal Medical Science And Technology Co., Ltd.
Model
EM 500
Published
2026-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
16973368290059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1697336829005916973368290059

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.

Regulatory Flags#

DUNS number
713341559
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974989947509ReefanMM05212026-05-06
06974989947516ReefanMM05222026-05-06
00031262115454HomedicsIFR-571HJ-10PK2025-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00045915831479Human TouchHuman Touch, LLCISA2026-01-12
00045915831486Human TouchHuman Touch, LLCISA2026-01-12
00045915831493Human TouchHuman Touch, LLCISA2026-01-12
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