ezRIP, Thorax, 1.5, 84″, Alice 5
ezRIP, Thorax, 1.5, 84", Alice
3manufacturers in China registered for this device type
1catalogue number
6510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Fujian (1), Jiangsu (1), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
Record
| Listed by | Respironics Inc., United States |
|---|---|
| FDA product code | MNR |
| Device type | Ventilatory Effort Recorder |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2375 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K013905 |
| Record published | 2016-09-01 |
| Record revised | 2021-01-29 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment temperature -4 to 140 °F; Storage environment humidity 15 to 95 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ezRIP, Thorax, 1.5, 84 inch, Alice | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sleepsense | S. L. P. Scientific Laboratory Products Ltd | 182 |
| TriplePlay | Dymedix Diagnostics Inc | 71 |
| Embla | S. L. P. Scientific Laboratory Products Ltd | 36 |
| Grass | S. L. P. Scientific Laboratory Products Ltd | 31 |
| Xltek | Embla Systems | 30 |
| Alice NightOne | Respironics Inc. | 22 |
| Onera STS | Onera B.V. | 21 |
| Natus | S. L. P. Scientific Laboratory Products Ltd | 21 |
| Night Shift | Advanced Brain Monitoring, Inc. | 19 |
| Neurovirtual | Neurovirtual USA, Inc. | 18 |
| SOMNOtouch Resp accessory | Somnomedics AG | 18 |
| zRIP | Respironics Inc. | 17 |
Showing 12 of 259. All products under Ventilatory Effort Recorder
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K183625 | 2019-10-18 |
| K131994 | 2013-10-17 |
| K052573 | 2005-12-13 |
| K021845 | 2004-05-20 |
| K990199 | 1999-04-19 |
| K973920 | 1998-05-14 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
| 2007-10-15 | Not classified | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. | 20950 units | 2009-09-01 |
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.