Xltek
XactTrace Reusable Belt - Medium Abdomen 78" cable length
3manufacturers in China registered for this device type
30catalogue numbers in this listing
5510(k) clearances naming this product 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 | Embla Systems, Canada |
|---|---|
| FDA product code | MNR |
| Device type | Ventilatory Effort Recorder |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2375 |
| 510(k) | K122516 |
| Record published | 2016-10-25 |
| Record revised | 2020-02-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1411542 | In distribution | |
| 2013032 | In distribution | |
| 2013031 | In distribution | |
| 1421039 | In distribution | |
| 2003011 | In distribution | |
| 1421035 | In distribution | |
| 1411548 | In distribution | |
| 2003010 | In distribution | |
| 011522 | In distribution | |
| 1421041 | In distribution | |
| 1411546 | In distribution | |
| 1421044 | In distribution | |
| 1421033 | In distribution | |
| 1421036 | In distribution | |
| 1411535 | In distribution | |
| 1421032 | In distribution | |
| 1421023 | In distribution | |
| 1421043 | In distribution | |
| 1411530 | In distribution | |
| 011291 | In distribution | |
| 1430000 | In distribution | |
| 1421042 | In distribution | |
| 1421034 | In distribution | |
| 1421040 | In distribution | |
| 1421038 | In distribution | |
| 1411517 | In distribution | |
| 1411541 | In distribution | |
| 2013030 | In distribution | |
| 1411524 | In distribution | |
| 1421037 | 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 |
| 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 |
| Alice PDx | Respironics Inc. | 17 |
Showing 12 of 259. All products under Ventilatory Effort Recorder
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180001 | 2019-09-27 |
| K173793 | 2019-03-01 |
| K122516 | 2013-02-21 |
| K111742 | 2011-08-31 |
| K073682 | 2008-08-08 |
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.