FDA.reportPublic FDA data

Beurer

Primary DI
10853879007994
Brand
Beurer
Company
BEURER NORTH AMERICA, L.P.
Model
CM100
Catalog number
Art.-No. 590.70
Device description
Massager
Published
2019-01-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
10853879007994PackageGS12In Commercial Distribution
00853879007997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085387900799410853879007994
00853879007997008538790079978538790079970853879007997

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
1-800-536-0366info@beurer.com

Regulatory Flags#

DUNS number
078497467
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
00810110200562BeurerBR70611.142026-06-09
00850003500164BeurerFM250649.472019-06-28
00850003500041BeurerIL51 Art.- No. 619.732019-03-04
00852547004108BeurerIL50 2016-09-24
00850003500478BeurerOT80792.972021-10-01
00810110200159BeurerBM69101.352023-11-07
10810110200156BeurerBM69101.352023-11-07
00853879007515BeurerPREMIUM 800W101.732023-10-23
10853879007512BeurerPREMIUM 800W101.732023-10-23
00810110200111BeurerAuto 400101.082023-10-20
00810110200128BeurerDeluxe 600101.072023-10-20
00810110200166BeurerPREMIUM 800101.552023-10-20
00810110200210BeurerEM29642.312023-10-20
00850018808705BeurerEM 49662.782023-10-20
00850018808910BeurerBM27651.992023-10-20
10810110200118BeurerAuto 400101.082023-10-20
10810110200125BeurerDeluxe 600101.072023-10-20
10810110200163BeurerPREMIUM 800101.552023-10-20
10810110200217BeurerEM29642.312023-10-20
10850018808702BeurerEM 49662.782023-10-20

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