Senior Living Alert Device AutoAlert With Indicator
7000AHB AutoAlert Button Senior Living
1manufacturer
4catalogue numbers in this listing
1510(k) clearance
3recalls on this 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 | Lifeline Systems, Inc., United States |
|---|---|
| FDA product code | ILQ |
| Device type | System, Communication, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3710 |
| Premarket notification | Exempt |
| Record published | 2021-03-19 |
| Record revised | 2021-10-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2018-06-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 300000491151 | In distribution | |
| 300000999281 | In distribution | |
| 1840578 | In distribution | |
| 300000350661 | Withdrawn |
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 |
|---|---|
| K914103 | 1991-09-27 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-11-13 | Class II | Software Manufacturing/Software Deployment | A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable. | 20201 | 2019-05-16 |
| 2015-07-23 | Class II | Process control | Irregular battery disconnection resulted in issues with Mobile Health Button (MHB) Charging. | 8,616 devices | 2020-11-10 |
| 2015-04-22 | Class II | Software design | Home communicator Model 7000L may not sense the phone line under certain unusual landline phone conditions. | 3189 devices total, 38 are subject to recall | 2016-08-24 |
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.