cos30008-01va04

Organization name

h/p/cosmos sports & medical gmbh

SRN

DE-MF-000006147

Manufacturer status

—

5 warnings recorded — scroll inside the panel to see all entries.

• CW011

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW138

  EUDAMED did not publish a description for this code.
• CW135

  EUDAMED did not publish a description for this code.
• 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 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.) ❚ Cardiac pacemaker ❚ Visual impairment (vision < 30% acc. to WHO) Further contraindications may occur. This has to be evaluated by the medical doctor. In case of relative contraindications permanent observation of the subject by medical staff is obligatory.

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

40505880017806

Basic UDI-DI

B-40505880017806

Reference / catalog number

cos30008-01va04

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDD [Directive 93/42/EEC 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 for any application where falling might cause an unacceptable risk (high speed or special applications, applications with subjects not able to jump off the running belt such as children, physically impaired, etc.)

Additional information URL

https://www.hpcosmos.com/en/contact-support/media-downloads/manuals

Clinical sizes

No clinical sizes registered for this device.

• Z129006TREADMILLS FOR PHYSIOTHERAPY AND/OR DIAGNOSTIC USES

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification