FDA.reportPublic FDA data

Medisana

Primary DI
04015588995385
Brand
Medisana
Company
Medisana GmbH
Model
NM 10L
Catalog number
99538
Device description
Electronically powered device with a vibrating mode to treat the neck muscles. Optionally with heating function by red light. It is typically used for physiotherapie e.g reduce muscular tensions for domestic use.
Published
2019-09-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
04015588998171PackageGS14In Commercial Distribution
04015588995385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015588998171040155889981714015588998171
04015588995385040155889953854015588995385

GMDN Terms#

Term, Definition table
TermDefinition
Electric massagerAn electrically-powered device with a vibrating head, or pads, designed to be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head, or pads, may optionally be heated, and may be interchangeable with others of different size and shape. It is typically used for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2488633175cservice@medisana.us

Regulatory Flags#

DUNS number
319241873
Device count
1
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
04015588920165medisanaMC 32L920162021-07-01
04015588999765medisanaBU 510999762021-07-01
04015588999802medisanaPM A10999802021-07-01
04015588996528MEDISANATM A75996522019-07-18
04015588987571MEDISANATM A75996522019-07-18

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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