FDA.reportPublic FDA data

medisana

Primary DI
04015588920165
Brand
medisana
Company
Medisana GmbH
Model
MC 32L
Catalog number
92016
Device description
Shiatsu massage cushion
Published
2021-07-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
04015588920165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015588920165040155889201654015588920165

GMDN Terms#

Term, Definition table
TermDefinition
Bed/chair electric massagerA mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
319241873
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04015588920219medisanaMM 80L920212021-08-12
04015588999765medisanaBU 510999762021-07-01
04015588999802medisanaPM A10999802021-07-01
04015588996528MEDISANATM A75996522019-07-18
04015588987571MEDISANATM A75996522019-07-18
04015588995385MedisanaNM 10L995382019-09-06

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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