Smartvest

Basic Information

• Brand Name: Smartvest
• Primary DI: B102125003S0200
• Version / Model: Clearway-I Air Pulse Generator
• Catalog Number: Clearway-I
• Company Name: ELECTROMED, INC.
• Labeler DUNS: 036514250
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-17
• Public Version: 2
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 9cd007ec-54dd-4540-8357-9dcd7d8257cb

Device Description

Electromed SmartVest Clearway-I Air Pulse Generator

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
38123	Chest-oscillation airway secretion-clearing system generator	A mains electricity (AC-powered) component of a high frequency chest wall oscillation airway secretion-clearing system intended to produce oscillating pressurized air-pulses that are delivered to an inflatable vest via a dedicated thick-walled hose. The air-pulses cause the vest to rapidly inflate and deflate against the chest wall of the patient promoting airway clearance by creating high frequency chest wall oscillation (HFCWO) resulting in the mobilization of bronchial secretions.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B102125003S0200	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K222496	000