PA-1
Portable Alarm System communication . powered
1manufacturer
1catalogue number
3510(k) clearances naming this product code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Contin Medical Device Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | MED Labs, Inc., 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 | 2023-07-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PA-1 | In distribution |
Same 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
| Clearance | Decision date |
|---|---|
| K935981 | 1994-02-17 |
| K923819 | 1992-11-06 |
| K903652 | 1990-08-24 |
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.