FREQUENCER
Basic Information
- Brand Name
- FREQUENCER
- Primary DI
- B401DYMV230
- Version / Model
- V2.3
- Catalog Number
- DYMV2.3
- Company Name
- Dymedso Inc
- Labeler DUNS
- 243498438
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-25
- Public Version
- 3
- Public Version Date
- 2021-01-25
- Public Version Status
- Update
- Public Device Record Key
- 454a5227-233f-4edf-999d-07627762c048
Device Description
The FREQUENCER provides airway clearance therapy and promotes bronchial drainage vibration in chest walls. The 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 bronchiti, bronchiectasis, cillary dyskinesia syndromes, asthma, muscular dystrophy, neuromuscular degenerative disorders, post-operative atelectasis and thoracic wall defects. Indications for this form of therapy are described in 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BYI | Percussor, Powered-Electric | Anesthesiology | 868.5665 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45292 | Chest-percussion airway secretion-clearing system | An assembly of devices designed to provide external mechanical percussion (rapid tapping) to the chest wall of a patient (child to adult) to loosen excessive airway secretions [mucus or sputum (phlegm)] to promote airway clearance and improve bronchial drainage for patients with respiratory disease [e.g., cystic fibrosis (CF), neuromuscular disease, bronchitis, bronchiectasis, chronic obstructive pulmonary disease (COPD)]. It consists of a mains electricity (AC-powered) applicator with connecting cable and a control unit. The device is portable and operated by a healthcare professional in a medical facility or in the home. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B401DYMV230 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103176 | 000 |