StarFormer
FOTONA d.o.o. · Model M008-3T · UDI-DI 03830054237728
Description
Fotona StarFormer is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. With handheld applicators - Fotona StarFormer is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes. o Relaxation of muscle spasm, o Prevention or retardation of disuse atrophy, o Increasing local blood circulation, o Muscle re-education, o Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, o Maintaining or increasing range of motion. With Chair Seat Applicator - Fotona StarFormer is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary incontinence in women.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-11-03 | Liberty Medical Solutions, LLC | The instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 to 2023 did not contain all of the appropriate warnings and contraindications. |
| 2012-01-06 | Ion Genius, Inc. | Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA |
| 2012-01-06 | Ion Genius, Inc. | Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA |
| 2012-01-06 | Ion Genius, Inc. | Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA |
| 2011-06-22 | eSwallow USA LLC | It was discovered that the firm was distributing medical devices without FDA approval. |
| 2009-01-25 | Zynex Medical, Inc. | Zynex notified customers that a malfunction in the IF 8000 can result in the device ceasing to operate, and in some instances,overheating and becoming hot to the touch. |
| 2008-06-11 | International Rehabilitative Sciences, Inc. | The charge current is leaking through two Diodes, which are supposed to block the reverse current, when the device is warm during the main battery charge operation, it then causes |
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