Frequencer
The filing describes Frequencer V2 and V2x as airway clearance devices that promote bronchial drainage by inducing vibration in the chest walls for chest physiotherapy. The filing…
The filing describes Frequencer V2 and V2x as airway clearance devices that promote bronchial drainage by inducing vibration in the chest walls for chest physiotherapy.
The filing identifies a frequency generator capable of producing frequencies between 20 and 65 Hz and states it connects to an external transducer placed on the patient chest.
Listed Item
The Frequencer provides airway clearance therapy and promotes bronchial drainage vibration in the chest walls. This device is intended to be a component of chest physiotherapy by providing a convenient method of external thorax manipulation. It is intended for patients having respiratory ailments which involve defective mucocillary clearance, as is typical in patients suffering from cystic fibrosis as well as chronic bronchitis, bronchiectasis, cillary dyskinesia syndromes, asthsma, muscular dystrophy, neuromuscular degenerative disorders, post-operative atelectasis and thoracic wall defects. Indications for this form of therapy are described in the Clinical Practice Guidelines for Postural Drainage Therapy of the American Association for Respiratory Care (AARC) published in 1991. This particular device provides a gentler, less painful form of therapy from the traditional “clapping” method of postural drainage therapy, allowing it to be used on patients who cannot be treated by clapping. The Frequencer is suitable for use in all patient-care environments including home health-care.
Model Configurations
The two named models have different adapters: V2x uses disposable filtered adapters for multi patient settings, while V2 has a permanent non filtering adapter for single patient use. These details are specific to the model identified.
Who Else Makes It
Registered in Chongqing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Chongqing Sonmol Technology Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 9 |
Record
| Listed by | Dymedso, Inc., United States |
|---|---|
| FDA product code | BYI |
| Device type | Percussor, Powered-Electric |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5665 |
| 510(k) | K103176 |
| Record published | 2016-12-19 |
| Record revised | 2021-01-25 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Over the counter | Yes |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V2.3 | In distribution | |
| V2.3 | In distribution | |
| V2X | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| G5® | General Physiotherapy, Inc. | 354 |
| InCourage® | Respiratory Technologies, Inc. | 252 |
| SmartVest | Electromed, Inc. | 172 |
| The Vest®System | Hill-Rom Services Pte, Ltd. | 97 |
| AffloVest | Tactile Systems Technology Inc | 39 |
| ClearChest® | Respiratory Technologies, Inc. | 31 |
| AffloVest | Movair, Inc. | 7 |
| Portex | ICU Medical, Inc | 4 |
| The Vest APX System | Hill-Rom Services Pte, Ltd. | 3 |
| Vibralung® | Westmed, Inc. | 3 |
| Vibralung Patient Kit | Westmed, Inc. | 2 |
| Monarch™ System | Hill-Rom Services Pte, Ltd. | 2 |
Showing 12 of 34. All products under Percussor, Powered-Electric
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K103176 | 2011-01-26 |
| K100749 | 2010-08-31 |
| K063645 | 2007-03-15 |
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.