h/p/cosmos proudly presents the new MDR and ISO 13485 certificates received today after our successful MDR audit in July 2022.
ahead of time is not only the h/p/cosmos slogan but also a registered trademark.
ahead of time also applies for these new certificates issued by the Notified Body TÜV Süd Product Service GmbH (CE0123) and for the successful assessment of technical documentation of the latest quasar med and pulsar med medical h/p/cosmos treadmill lines with MCU6.
extract of MDR certificate:
EU Quality Management System Certificate (MDR)
Pursuant to Regulation (EU) 2017/745 on Medical Devices, Annex IX Chapters I and III (Class IIa and Class IIb Devices)
No. G10 045283 0027 Rev. 00
Manufacturer: h/p/cosmos sports & medical gmbh, Am Sportplatz 8, 83365 Nussdorf – Traunstein, GERMANY
SRN Manufacturer: DE-MF-000006147
The Certification Body of TÜV SÜD Product Service GmbH certifies that the manufacturer has established, documented and implemented a quality management system as described in Article 10 (9) of the Regulation (EU) 2017/745 on medical devices. Details on device categories covered by the quality management system are described on the following page(s).
The Report referenced below summarises the result of the assessment and includes reference to relevant CS, harmonized standards and test reports. The conformity assessment has been carried out according to Annex IX Chapter I and Ill of this regulation with a positive result.
The quality management system assessment was accompanied by the assessment of technical documentation for devices selected on a representative basis.
Valid from: 2022-11-18 until: 2027-11-17
Classification: IIb
Device Group: Z129006 - TREADMILLS FOR PHYSIOTHERAPY AND/OR DIAGNOSTIC USES
Intended Purpose: 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.)
Download MDR Certificate