cos30004-01va04

Organization name

h/p/cosmos sports & medical gmbh

SRN

DE-MF-000006147

Manufacturer status

—

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• CW273

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• CW010

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• CW138

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• CW135

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• CW999

  Contraindications Absolute contraindications (have to be excluded before the treadmill is used) • Acute myocardial infarction (within 2 days) • Instable angina pectoris • Cardiac arrhythmia pathology and/or limited hemodynamics • Symptomatic massive aortic stenosis • Uncompensated / uncontrolled heart insufficiency • Acute pulmonary embolism or pulmonary infarction • Acute endocarditis, myocarditis, pericarditis • Acute aortic dissection • Acute coronary syndrome • Acute phlebothrombosis of the lower extremities • Febrile infections • Pregnancy • Acute thrombosis • Fresh wounds e.g. after surgery • Acute fracture • Damaged disc or traumatic disease of the spine • Epilepsy • Inflammations • Acute migraine • uncontrolled heart failure • dissecting aneurysm • recent aortic surgery and ECG abnormalities, such as abnormal ST-segment response (horizontal, planar or downslopingdepression of >1 mm, T-wave elevation of > 1 mm in leads without Q-waves, and Twavechanges such as inversion and pseudo-normalization when an inverted T-wave becomes upright. Relative contraindications (The application may be started if the possible benefits exceed the risks. The decision has to be made by the medical doctor before the treadmill is used) • Left main coronary stenosis • Main artery disease • Cardiac valve disease of moderate severity • Known electrolyte imbalance • Arterial hypertonia (RR > 200 mm Hg syst. > 110 mm Hg diast.) • Tachyarrhythmia or bradyarrhythmia • Hypertrophic cardiomyopathy and other forms of outflow tract obstruction • Higher degree atrioventricular AV-blocking • Anemia • Physical and/or mental disabilities leading to inability to exercise adequately • Partially invasive medical devices (probes, infusions, catheters, external fixators, etc.)

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

40505880031420

Basic UDI-DI

4050588cos30003-015X

Reference / catalog number

cos30004-01va04

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

h/p/cosmos medical treadmills are intended for walking or running in place for - Recreational fitness training (incl. athletes) - Gait training (with or without body weight support) h/p/cosmos medical treadmills can be used in combination with external devices for walking or running in place as - Stressing devices for neuromuscular and biomechanical measurements (e.g. EEG, EMG, motion analysis) - Stressing devices for cardiovascular measurements (e.g. ECG) - Stressing devices for cardiopulmonary measurements (e.g. ergospirometry) Prescribed fall prevention device for any application where falling might cause an unacceptable risk (osteoporosis, high speed or special applications, applications with subjects not able to jump off the running belt such as children, physically impaired, etc.). product family: treadmill h/p/cosmos 170-190/65 MCU6 (quasar, pulsar)

Additional information URL

https://www.hpcosmos.com/sites/default/files/uploads/documents/20210922_hpcosmos_treadmill_manual_ifu_170-190_65_mcu6_sport-med_en.pdf

Clinical sizes

No clinical sizes registered for this device.

• Z129006TREADMILLS FOR PHYSIOTHERAPY AND/OR DIAGNOSTIC USES

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