FDA.reportPublic FDA data

Hand-held deep-tissue electromagnetic stimulator

Definition
A 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.
GUDID devices
66
Last updated
2026-06-11 06:05:52

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00851329005258ActiPatchBioElectronics Corporation0882021-06-09
06977168990013NuonShenzhen Nuon Medical Equipment Co., Ltd.HD-442026-04-21
06977168990129NuonShenzhen Nuon Medical Equipment Co., Ltd.HD-702026-04-21
06977168990150NuonShenzhen Nuon Medical Equipment Co., Ltd.HD-59A2026-04-21
06977168990273NuonShenzhen Nuon Medical Equipment Co., Ltd.HD-59B2026-04-21
07640161462014BEMER Therapy SystemsBemer Int. AGB.BOX Classic2017-05-03
00851979007282OrthoCor MedicalCaerus Corp.Pemf NOW2025-08-11
00851979007657OrthoCor MedicalCaerus Corp.ONE2025-08-11
07640161460904BEMER Classic-Set Evo (B.Body)Bemer Int. AGBEMER Therapy System Evo2025-03-24
07640161460959BEMER Classic-Set Evo (B.Bed)Bemer Int. AGBEMER Therapy System Evo2025-03-24
07640161464100BEMER Basic-Set EvoBemer Int. AGBEMER Therapy System Evo2025-03-24
07640161464117BEMER Premium-Set EvoBemer Int. AGBEMER Therapy System Evo2025-03-24
00851979007305OrthoCor MedicalCaerus Corp.Activ8 Back - Standard2025-03-10
00851979007312OrthoCor MedicalCaerus Corp.Activ8 Knee - XS2025-03-10
00851979007435OrthoCor MedicalCaerus Corp.Activ8 Knee - XL2025-03-10
00851979007442OrthoCor MedicalCaerus Corp.Activ8 Back - XS2025-03-10
00851979007503OrthoCor MedicalCaerus Corp.Activ8 Back - XL2025-03-10
00851979007510OrthoCor MedicalCaerus Corp.Activ8 Ankle2025-03-10
00851979007527OrthoCor MedicalCaerus Corp.Activ8 Knee - Standard2025-03-10
00851979007534OrthoCor MedicalCaerus Corp.Activ8 Wrist2025-03-10
00851979007558OrthoCor MedicalCaerus Corp.Activ8 Neck2025-03-10
00851979007565OrthoCor MedicalCaerus Corp.Activ8 Shoulder2025-03-10
00851979007572OrthoCor MedicalCaerus Corp.Activ8 Elbow2025-03-10
00851979007596OrthoCor MedicalCaerus Corp.Activ8 Universal2025-03-10
00851979007619OrthoCor MedicalCaerus Corp.Activ8 Foot2025-03-10
07640161460065B.Pad EvoBemer Int. AGBEMER Therapy System Evo 2025-03-05
07640161460072B.Body EvoBemer Int. AGBEMER Therapy System Evo2025-03-05
07640161460089B.Bed EvoBemer Int. AGBEMER Therapy System Evo2025-03-05
07640161460096B.Sit EvoBemer Int. AGBEMER Therapy System Evo2025-03-05
07640161460188B.Spot EvoBemer Int. AGBEMER Therapy System Evo2025-03-05
07640161460706B.Box EvoBemer Int. AGBEMER Therapy System Evo2025-03-05
00851979007015OrthoCor MedicalCaerus Corp.Active System Knee - XS2025-03-03
00851979007022OrthoCor MedicalCaerus Corp.Active System Knee - XL2025-03-03
00851979007039OrthoCor MedicalCaerus Corp.Active System Back - XS2025-03-03
00851979007046OrthoCor MedicalCaerus Corp.Active System Back - XL2025-03-03
00851979007336OrthoCor MedicalCaerus Corp.Active System Ankle2025-03-03
00851979007367OrthoCor MedicalCaerus Corp.Active System Wrist2025-03-03
00851979007381OrthoCor MedicalCaerus Corp.Active System Neck2025-03-03
00851979007404OrthoCor MedicalCaerus Corp.Active System Shoulder2025-03-03
00851979007428OrthoCor MedicalCaerus Corp.Active System Elbow2025-03-03
00851979007466OrthoCor MedicalCaerus Corp.Active System Foot2025-03-03
00851979007480OrthoCor MedicalCaerus Corp.Active System Universal2025-03-03
00851979007664OrthoCor MedicalCaerus Corp.Active System Back - Standard2025-03-03
00851979007671OrthoCor MedicalCaerus Corp.Active System Knee - Standard2025-03-03
06974000130002HealthpalXiamen Healthpal Electronic Co., Ltd.FE-01612025-01-04
00850061407054LS Pro SystemsWELLNESS WITHOUT LIMITS LLCXL2002024-05-09
00850061407160LS Pro SystemsWELLNESS WITHOUT LIMITS LLCXL200-SI2024-05-09
00851329005241ActiPatch BioElectronics Corporation0882021-06-09
00851329005470ActiPatch BioElectronics Corporation0882021-06-09
00851329005487ActiPatch BioElectronics Corporation0882021-06-09
00851329005494ActiPatch BioElectronics Corporation0882021-06-09
80851329005155ActiPatch BioElectronics Corporation0882021-06-09
00851329005128RecoveryRxBioElectronics Corporation 0882021-03-03
00851329005463KT RECOVERY+ WAVEBioElectronics Corporation0882021-03-03
07640161460218Bemer Therapy SystemBemer Int. AGB.SIT2021-02-11
07640161461086Bemer Therapy SystemBemer Int. AGB.BODY Professional2021-02-11
00851329005012ActiPatchBioElectronics Corporation0882020-07-23
00851329005159ActiPatchBioElectronics Corporation0882020-07-23
00851329005203ActiPatchBioElectronics Corporation0772020-07-23
00851329005340ActiPatchBioElectronics Corporation0882020-07-23
07640161461055BEMER Therapy SystemsBemer Int. AGProfessional2017-05-03
00851561006105Trophy SkinTROPHY SKIN, INCREJUVATONEMD2020-01-31
06430063200002Nexstim NBS softwareNexstim Oyj52016-09-21
07640161461017BEMER Therapy SystemsBemer Int. AGB.BOX Classic2017-05-03
07640161461048BEMER Therapy SystemsBemer Int. AGB.BOX Professional2017-05-03
00851329005050ActiPatchBioElectronics Corporation 0882015-07-22