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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
088095244976843H Smart Massage Bed3H, Co., LtdISA2026-07-29
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088095244977073H Smart Massage Bed3H, Co., LtdISA2026-07-29
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088095244977213H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977383H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977453H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977523H Smart Massage Bed3H, Co., LtdISA2026-07-29
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-29
088095244976773H Smart Massage Bed3H, Co., LtdISA2026-07-28
06971712725908MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-25
00850080988657AUVONUAN HEALTHCARE LIMITEDNGX2026-07-22
00810140063106Renpho Massage GunJoicom CorporationISA2026-07-21
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-09
00850080988572AUVONUAN HEALTHCARE LIMITEDNGX2026-07-03
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-03
06978452680122AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-07-01
00850085485021AUVONAnsion Technology (GuangDong) Co. Ltd.NGX2026-06-26
00850085485038AUVONAnsion Technology (GuangDong) Co. Ltd.NGX2026-06-26
00850085485045AUVONAnsion Technology (GuangDong) Co. Ltd.NGX2026-06-26
00850085485007AVCOOAnsion Technology (GuangDong) Co. Ltd.NGX2026-06-25
00850080988473AUVONUAN HEALTHCARE LIMITEDNGX2026-06-24
00810140063076RenphoJoicom CorporationISA2026-06-23
06972433811246JermeiShenzhen Jermei Medical Device Technology Co.,LtdISA2026-06-10
06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
00850071298017Smart-RSTHyperion Medical Technologies, Inc.ISA2026-06-02
06971712722075MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-06-02