FDA.reportPublic FDA data

BEMER Therapy Systems

Primary DI
07640161461017
Brand
BEMER Therapy Systems
Company
Bemer Int. AG
Model
B.BOX Classic
Catalog number
420100
Published
2017-05-03
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

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
07640161461017PackageGS11In Commercial Distribution
07640161461031PackageGS14In Commercial Distribution
07640161462014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640161461017076401614610177640161461017
07640161461031076401614610317640161461031
07640161462014076401614620147640161462014

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held deep-tissue electromagnetic stimulatorA battery-powered, hand-held device designed to apply an electromagnetic (EM) field to body deep tissues to help reduce pain associated with musculoskeletal/neurological disorders (e.g., arthritis, sciatica) and/or to treat soft-tissue wounds and injuries with no production of a therapeutic deep heat. It is a self-contained electronic unit with controls intended to be applied to the body to emit short-time pulsed, radio-frequency energy [pulsed electromagnetic fields (PEMF)] to tissues at a level below the patient's heat sensory perception threshold. It is not intended to apply an electric current directly to the body. The device is intended to be used in clinical and home settings.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
448002860
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
07640161464124Light Pack EvoBEMER Therapy System Evo4150202025-03-24
07640161460195B.Light Clear EvoBEMER Therapy System Evo4345002025-03-05
07640161460201B.Light Restore EvoBEMER Therapy System Evo4346002025-03-05
07640161460904BEMER Classic-Set Evo (B.Body)BEMER Therapy System Evo4143202025-03-24
07640161460959BEMER Classic-Set Evo (B.Bed)BEMER Therapy System Evo4144202025-03-24
07640161464100BEMER Basic-Set EvoBEMER Therapy System Evo4141202025-03-24
07640161464117BEMER Premium-Set EvoBEMER Therapy System Evo4142202025-03-24
07640161460065B.Pad EvoBEMER Therapy System Evo 4341002025-03-05
07640161460072B.Body EvoBEMER Therapy System Evo4343002025-03-05
07640161460089B.Bed EvoBEMER Therapy System Evo4344002025-03-05
07640161460096B.Sit EvoBEMER Therapy System Evo4342002025-03-05
07640161460188B.Spot EvoBEMER Therapy System Evo4340002025-03-05
07640161460706B.Box EvoBEMER Therapy System Evo4240202025-03-05
07640161460218Bemer Therapy SystemB.SIT4314002021-02-11
07640161461086Bemer Therapy SystemB.BODY Professional4302012021-02-11
07640161461055BEMER Therapy SystemsProfessional4102012017-05-03
07640161462014BEMER Therapy SystemsB.BOX Classic4201002017-05-03
07640161461048BEMER Therapy SystemsB.BOX Professional4202002017-05-03

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