Soberlink
The FDA filing identifies the Soberlink Cellular Device as a handheld breath alcohol measurement device. It is intended to measure alcohol in human breath, with measurements used in the…
The FDA filing identifies the Soberlink Cellular Device as a handheld breath alcohol measurement device. It is intended to measure alcohol in human breath, with measurements used in the diagnosis of alcohol intoxication.
The device takes a deep lung breath sample, calculates a blood alcohol level, and sends the reading, physical location, and a digital image to the Sober Sky Web Portal and device screen for review.
Measurement and Data Transfer
The filing describes integrated GPS, a digital imager, and a cellular modem. It states that the device is for prescription and over-the-counter use.
Who Else Makes It
Concentrated in Guangdong (10), Zhejiang (2), Hunan (1). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| PAN-International Precision Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Dong Guan EEK Electronic Technology Co., Limited | Dong Guan | Guangdong | Contract manufacturer | 2 |
| Fujian Ruili Electronics Co., Ltd. | Ningde | Fujian | Contract manufacturer | 2 |
| Huizhou Maxway Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 2 |
| Hanwei Electronics Group Corporation | Zhengzhou | Henan | Contract manufacturer | 1 |
| Sunton Electronics Co., Ltd. | Heyuan | Guangdong | Contract manufacturer | 1 |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Changsha U DE Toptech Electronic Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 3 |
| E-Business International Inc. | Shenzhen | Guangdong | Exporter | 2 |
| Rayco Electronic Ltd. | Dong Guan | Guangdong | Manufacturer | 2 |
| Shenzhen Well Electric Co., Limited | Shenzhen | Guangdong | Manufacturer | 2 |
Showing 12 of 16. All 16 manufacturers in China registered for Devices, Breath Trapping, Alcohol
Record
| Listed by | Soberlink Healthcare LLC, United States |
|---|---|
| FDA product code | DJZ |
| Device type | Devices, Breath Trapping, Alcohol |
| Device class | Class 1 |
| Regulation | 21 CFR 862.3050 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K160613 |
| Record published | 2021-04-07 |
| Record revised | 2024-07-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2024-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SOBERLINK GSM2 – 02 | In distribution | |
| SOBERLINK CELLULAR CATM | In distribution | |
| SOBERLINK LTE – 06 | In distribution | |
| SOBERLINK 7.0 | In distribution | |
| SOBERLINK CONNECT ST – 08 | In distribution | |
| SOBERLINK Connect – 01 | In distribution | |
| SOBERLINK GSM1 REFURB – 05 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Checkpoint | AlcoPro Inc | 6 |
| AlcoBreath Tube | AlcoPro Inc | 4 |
| co-innovation | Co-Innovation Biotech Co., Ltd. | 1 |
| Easy@Home Fuel Cell Breathalyzer | Easy Healthcare Corporation | 1 |
| Accutest Breath Alcohol Detector | Jant Pharmacal Corp. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160613 | 2016-07-14 |
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.