cos30004va01

Trade name

not provided

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

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40505880005544

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

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B-40505880005544

Reference / catalog number

cos30004va01

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

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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.) product family: treadmill h/p/cosmos 170-190/65 (quasar, pulsar)

Additional information URL

https://www.hpcosmos.com/sites/default/files/uploads/documents/20181213_cos105000_h-p-cosmos_instructions_for_use_170-190_65_hpc_master_rev_1.03.pdf

Clinical sizes

No clinical sizes registered for this device.

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

• Z129006TREADMILLS FOR PHYSIOTHERAPY AND/OR DIAGNOSTIC USES

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• CW273

  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.

No certificate specifically references this device's Basic UDI-DI.