Who else makes this device?

Name: PRiO-mini
Brand: PRiO-mini

Physical Medicine › ProstheticSystem, Communication, Powered

PRiO-mini

The PRiO-mini is an iPad based communication tool featuring the iPad-mini and the popular LAMP Words for Life (WFL) Vocabulary and iPad-mini. LAMP WFL is a full vocabulary communication app…

Registry build 21.09.26

The PRiO-mini is an iPad based communication tool featuring the iPad-mini and the popular LAMP Words for Life (WFL) Vocabulary and iPad-mini. LAMP WFL is a full vocabulary communication app that combines the power of UNITY with the principles and strategies of Language Acquisition through Motor Planning (LAMP). The WFL vocabulary is appropriate for individuals with a wide range of language and communication skills.

1manufacturer

1catalogue number

4510(k) clearances naming this product code

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code ILQ
Manufacturer	City	Province	Registered as	Device types
Shenzhen Contin Medical Device Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	3

Record

Regulatory record for PRiO-mini
Listed by	Prentke Romich Co., United States
FDA product code	ILQ
Device type	System, Communication, Powered
Device class	Class 2
Regulation	21 CFR 890.3710
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2016-09-24
Record revised	2018-03-29 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Over the counter	Yes
Label carries	serial number
Storage	Handling environment temperature 0 to 45 °C; Storage environment temperature -20 to 50 °C; Handling environment humidity up to 95 % RH
Sizes	Weight 1.4 lb

Catalogue Numbers

Catalogue numbers for PRiO-mini
Catalogue number	Size	Status
PRiO-mini	Weight 1.4 lb	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
GEN4 Direct Access	Curbell Medical Products, Inc.	1,343
GEN4 Interactive	Curbell Medical Products, Inc.	1,005
GEN4 Plus, Direct Access	Curbell Medical Products, Inc.	599
Responder 5, Interactive	Curbell Medical Products, Inc.	573
Series 8 Anacom MedTek	Anacom Medtek	519
Series 7 Anacom MedTek	Anacom Medtek	312
GEN4 Plus, Responder 5, Enhanced	Curbell Medical Products, Inc.	112
Responder 5, Enhanced	Curbell Medical Products, Inc.	108
Tobii Dynavox	Tobii Dynavox LLC	44
Nova Chat	Prentke Romich Co.	44
GEN4 Plus, Responder 5, Standard	Curbell Medical Products, Inc.	33
Saltillo	Prentke Romich Co.	27

Showing 12 of 1,439. All products under System, Communication, Powered

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K925387	1993-03-29
K925527	1993-03-22
K914259	1992-02-27
K902206	1990-05-29

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.