Elite Pillowspeaker

Elite series pillow speakers followed by any alphanumeric characters denoting low energy circuitry difference and cable length.

Registry build 21.09.26
1manufacturer
15catalogue numbers in this listing

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code IQA
Manufacturer City Province Registered as Device types
Yuiyn HOO Industrial Limited Dong Guan Guangdong Contract manufacturer 3

Record

Regulatory record for Elite Pillowspeaker
Listed by Crest Healthcare Supply
FDA product code IQA
Device type System, Environmental Control, Powered
Device class Class 2
Regulation 21 CFR 890.3725
Premarket notification Exempt
Record published 2022-11-02

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries manufacturing date
Sizes Length 8 ft
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Elite Pillowspeaker
Catalogue number Size Status
EN52CCEEIIXXXXTAL Length 8 ft In distribution
NUHSDADVWFIRH Length 8 ft In distribution
NUHSDADVWFIRHK Length 8 ft In distribution
DARPSM5006 Length 8 ft In distribution
DARPSM5002 Length 8 ft In distribution
DARPSM5000 Length 8 ft In distribution
DARPSM5007 Length 8 ft In distribution
XN52CCEIXXXXTAAYL Length 8 ft In distribution
EN54CCEEIIXXXXTAL Length 8 ft In distribution
XT53CCEIXXXXTAAYL Length 8 ft In distribution
DARPSM5001 Length 8 ft In distribution
DARPSM50098 Length 8 ft In distribution
DARPSM50096 Length 8 ft In distribution
DARPSM5008 Length 8 ft In distribution
XT52CCEIXXXXTAAYL Length 8 ft In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
GEN4 Digital Curbell Medical Products, Inc. 922
GEN4 Interactive Curbell Medical Products, Inc. 456
GEN4 Plus, Direct Access Curbell Medical Products, Inc. 142
Arial Securitas Healthcare LLC 96
Ascom Ascom Sweden AB 77
Elite Digital Crest Healthcare Supply 71
Amplion Care Assurance Amplion Clinical Communications, Inc. 67
Elite Infrared Crest Healthcare Supply 59
Responder 5, Standard Curbell Medical Products, Inc. 33
Excel Digital Crest Healthcare Supply 28
Responder 5, Standard,no Entertainment Curbell Medical Products, Inc. 28
Excel EntertainIR Crest Healthcare Supply 24

Showing 12 of 819. All products under System, Environmental Control, Powered

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