spineFiT Smart Home

Trade name

spineFiT Smart Home

04260740820252

426074082HOME9A

Reference / catalog number

Smart Home 1

GS1

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Nicht-aktive Therapieliege zur eigenständigen Durchführung der patientengesteuerten spinalen Dekompression/Traktion durch Eigenkraft des Patienten, bestimmt für die Anwendung durch Laien im häuslichen Umfeld; auch im professionellen Umfeld einsetzbar. Ohne motorische Funktionen und ohne elektrische Höhenverstellung.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z120602PHYSIOTHERAPY EQUIPMENT

1 warning recorded — scroll inside the panel to see all entries.

• Maximum load 150 kg Warning! Read the safety warnings and the instructions. Failure to follow the safety warnings and the instructions can result in personal injury or damage to the equipment. Keep the safety warnings and the instructions for future reference. Before starting your therapy, consult a physician to confirm that your state of health allows you to perform this therapy. Do not use the device if any of the following contraindications apply to you: – recent fractures in the spinal region – tumours in the spinal region – complete or incomplete spinal cord injury (paraplegia) – severe osteoporosis – slipped vertebrae – congenital deformities of the spine – hyperkyphosis due to Scheuermann's disease – ankylosing spondylitis (Bechterew's disease) – age-related hyperkyphosis ("dowager's hump") – inflammatory diseases – spina bifida / cauda equina syndrome – patients who have undergone surgery with metal implants in the spinal region – spondylolisthesis grade 2 or higher – aneurysm – increased intracranial pressure – pulmonary diseases – during pregnancy – patients under 15 years of age Caution – relative contraindications (use only after consulting a physician): – obesity – high blood pressure (hypertension) – motor impairment of the arms – plexus palsy The use of this equipment by children or by persons with physical, sensory, mental or motor disabilities, or with a lack of experience and knowledge, can give rise to hazards. Persons responsible for their safety must provide explicit instructions or supervise the use of the equipment. If you experience nausea, dizziness or any other unusual symptoms, stop your therapy immediately and consult a physician.

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