FDA.reportPublic FDA data

BEMER Therapy Systems

Primary DI
07640161462014
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
OTC
true

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric
NGXStimulator, Muscle, Powered, For Muscle Conditioning

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2

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.

Regulatory Flags#

DUNS number
448002860
Device count
1
Serial number
true

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
07640161461017BEMER Therapy SystemsB.BOX Classic4201002017-05-03
07640161461048BEMER Therapy SystemsB.BOX Professional4202002017-05-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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03770018808093actiTENSSUBLIMEDNGX2026-05-27
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03770018808116actiTENSSUBLIMEDNGX2026-05-27
03770018808253actiTENS MiniSUBLIMEDNGX2026-05-27
03770018808260actiTENS MiniSUBLIMEDNGX2026-05-27
00199874125305Muscle StimulatorShenzhen Yiran Intelligence Co., Ltd.NGX2026-05-08
16973368290059MedisanaZhangzhou Easepal Medical Science And Technology Co., Ltd.ISA2026-04-30
07630039101855MASTERPULS®Storz Medical AGISA2026-04-15
00810060832851Venus NovaVenus Concept Inc.NGX2026-04-15
00045915831424Human TouchHuman Touch, LLCISA2026-01-12
00045915831431Human TouchHuman Touch, LLCISA2026-01-12
00045915831448Human TouchHuman Touch, LLCISA2026-01-12
00045915831455Human TouchHuman Touch, LLCISA2026-01-12
00045915831462Human TouchHuman Touch, LLCISA2026-01-12
00045915831479Human TouchHuman Touch, LLCISA2026-01-12
00045915831486Human TouchHuman Touch, LLCISA2026-01-12
00045915831493Human TouchHuman Touch, LLCISA2026-01-12
00810093080786PainPod Hi-Dow International IncorporatedNGX2025-12-09
00810093080793PainPod Hi-Dow International IncorporatedNGX2025-12-09
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00092237621974TwinStimDrive Devilbiss HealthcareNGX2025-08-15
08800205600003NeuclareDeepsonbio Co., LtdISA2025-08-08
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.NGX2025-07-21
08809643652087CERAGEM Master V9CERAGEM Co., Ltd.ISA2025-07-15
00194346469680EQUATEWAL-MART STORES, INC.NGX2025-06-13