AffloVest

Basic Information

• Brand Name: AffloVest
• Primary DI: 00814321020025
• Version / Model: 8100
• Company Name: INTERNATIONAL BIOPHYSICS CORPORATION
• Labeler DUNS: 788403103
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-11-24
• Public Version: 4
• Public Version Date: 2022-05-03
• Public Version Status: Update
• Public Device Record Key: 4ae08e67-2816-47fd-9b8c-9f3ca64b15e1
• Distribution End Date: 2022-04-29

Device Description

The AffloVest is comprised of a vest of synthetic polymer fabric with oscillating vibratory motors organized into zones. The vest may be run on battery or A/C power from a standard wall outlet. The AffloVest is intended for promoting airway clearance and improvement of bronchial drainage by enhancing mobilization of bronchial secretions where external manipulation of the thorax is the physician’s choice of treatment.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• 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
38124	Chest-oscillation airway secretion-clearing system	An assembly of devices designed to provide high frequency chest wall oscillation (HFCWO) for external chest wall manipulation intended 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) oscillating pressurized air generator, an inflatable vest (jacket) to be worn by the patient and a connecting hose. It is intended to be operated by a healthcare professional in a professional setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814321020025	GS1

Premarket Submissions

Submission Number	Supplement Number
K122480	000