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510(k) Data Aggregation
K Number
K220625Device Name
ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System
Manufacturer
Date Cleared
2022-04-06
(34 days)
Product Code
Regulation Number
882.5805Why did this record match?
Applicant Name (Manufacturer) :
REMED Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ALTMS Magnetic Stimulation Therapy System (also Blossom TMS Therapy System) is indicated for the treatment of Major Depressive Disorder in adult patients, who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Device Description
The ALTMS Magnetic Stimulation Therapy System (also Blossom TMS Therapy System) is a computerized, electromechanical medical device that generates and delivers non-invasive, magnetic stimulation using brief duration rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation.
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K Number
K202537Device Name
ALTMS Magnetic Stimulation Therapy System
Manufacturer
Date Cleared
2021-11-26
(451 days)
Product Code
Regulation Number
882.5805Why did this record match?
Applicant Name (Manufacturer) :
REMED Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ALTMS Magnetic Stimulation Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients, who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Device Description
The ALTMS Magnetic Stimulation Therapy System is a computerized, electromechanical medical device that generates and delivers non-invasive, magnetic stimulation using brief duration rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation. The ALTMS Magnetic Stimulation Therapy System is an integrated system consisting of a combination of hardware, software, and accessories. It includes a Mobile console which houses the electronic components, provides mechanical support for the ferromagnetic Treatment Coil. The Standing Arm, an accessory device included in the ALTMS provides the coil positioning function.
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K Number
K202031Device Name
Talent-Pro Electromagnetic Stimulator
Manufacturer
Date Cleared
2021-05-06
(288 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Remed Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Talent-Pro™ Electromagnetic Stimulator is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
The Talent-Pro™ Electromagnetic Stimulator is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes.
Indications for Use for Muscle Stimulators:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
Device Description
The Talent-Pro Electromagnetic Stimulator is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes, prevention or retardation of disuse atrophy. Talent-Pro Electromagnetic Stimulator consists of the Main body, Transducer for magnetic stimulation
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