Instrumentation Difra

The air caloric stimulator is a device that delivers a stream of air to the ear canal at controlled rates of flow and temperature and that is intended for vestibular function testing of a…

Registry build 21.09.26

The air caloric stimulator is a device that delivers a stream of air to the ear canal at controlled rates of flow and temperature and that is intended for vestibular function testing of a patient’s body balance system. The vestibular stimulation of the semicircular canals produces involuntary eye movements. The handle is equipped with an otoscope head where a disposable ear tip can be fixed for easy management of hygiene. The otoscope handle provides also a magnifying glass and integrated light to inspect the ear canal and the tympanic membrane without obstructing the stimulation. CoolStar is ideal when water can not be used for stimulation (tympanic membrane perforation, …), when water inlet and outlet are not available in the examination room and when ambient room temperature exceeds 22°C. Cool and warm air caloric stimulator Minimal temperature reachable: 10°C with water temperature in glass jar below 50°C Maximal temperature reachable: 49,8°C Air flow: fixed, from 8 to 10l/min, without ear tip Timer: Five stimulation times are available: 40, 60, 80,100 and 120s Intended user: Qualified users, ENT doctors, audiologist, nurses and medical staff trained to the device and to the caloric testing process. Glass jar with connection for demineralized water, holder and connections

1manufacturer
6catalogue numbers in this listing

Who Else Makes It

Registered in Beijing.

Chinese manufacturers registered for FDA product code KHH
Manufacturer City Province Registered as Device types
Isen Tech.&Trading Co., Ltd. Beijing Beijing Manufacturer 2

Record

Regulatory record for Instrumentation Difra
Listed by Instrumentation Difra SA
FDA product code KHH
Device type Stimulator, Caloric-Air
Device class Class 1
Regulation 21 CFR 874.1800
Premarket notification Exempt
Record published 2020-05-18
Record revised 2020-11-19 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Latex Contains natural rubber latex
Label carries manufacturing date, serial number
Storage Storage environment humidity 30 to 90 % RH; Handling environment humidity 30 to 90 % RH; Storage environment temperature 5 to 55 °C; Handling environment temperature 5 to 35 °C
Sizes Height 11.5 cm; depth 34.5 to 45.5 cm; length 31 cm; weight 5 kg

Catalogue Numbers

Catalogue numbers for Instrumentation Difra
Catalogue number Size Status
CoolStar 230V 3.0 Height 11.5 cm In distribution
AirStar 2.0 Depth 34.5 cm In distribution
CoolStar 230V 3.0 Height 11.5 cm In distribution
CoolStar 115V 3.0 Height 11.5 cm In distribution
CoolStar 115V 3.0 Height 11.5 cm In distribution
AirStar 2.0 Depth 34.5 cm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
ICS Natus Medical Denmark ApS 4
GN Otometrics A/S Natus Medical Denmark ApS 3
Instrumentation Difra SA Instrumentation Difra SA 2
Interacoustics Interacoustics A/S 1
Atmos Atmos Medizintechnik Gmbh & Co. KG 1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer