Publicité
Les langues disponibles
Les langues disponibles
Environmental specifications
Operating conditions
ambient temperature
relative humidity
atmospheric pressure
Safety agency approvals
ETL Listed
The Standard for Safety of Medical Electrical Equipment :
In progress
Product classification
Flammability
Manufacturer Registrations
FDA registered company as a manufacturer and as a contract manufacturer.
Manufacturer quality system meets the requirements of:
ISO 13485:2016 certified company.
USER MANUAL - 303-9003-ENG R3
41 °F ~ 104 °F
Less than 93% non-condensing
700 to 1060 hPa
2
Edition
nd
Class 1 Device (USA)
Canada Class 1 = a non-powered flotation therapy
mattress
USA : Class 1 = IKY - Non powered flotation therapy
mattress
Meets the standards 16 CFR 1632 & 16 CFR 1633,
CAL TB 129, BFD IX-11
FDA 21 CFR, PART 820-QSR-Current Good Manufacturing
Practices (CGMP) for medical devices.
5 °C ~ 40 °C
Less than 93% non-condensing
700 to 1060 hPa
7
Publicité
