The PercussiveNEB® device is a single-patient use percussor, which makes it possible for individuals to receive multiple high frequency treatments while using the same device. Other…
The PercussiveNEB® device is a single-patient use percussor, which makes it possible for individuals to receive multiple high frequency treatments while using the same device. Other percussive devices need to be cleaned between patients and also require waiting for the equipment to become available. It is easy to use with quick set-up time and patient initiates and controls the percussion levels. It can be used by patients in the hospital or in the home
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Vortran PercussiveNEB | Listed by | Vortran Medical Technology 1, Inc., United States |
| FDA product code | NHJ |
| Device type | Device, Positive Pressure Breathing, Intermittent |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K003684 |
| Record published | 2016-06-14 |
| Record revised | 2018-07-06 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10 |
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.