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510(k) Data Aggregation
K Number
K141355Device Name
VOLUMETRIC INCENTIVE SPIROMETER
Manufacturer
BESMED HEALTH BUSINESS CORPORATION
Date Cleared
2014-09-03
(103 days)
Product Code
BWF
Regulation Number
868.5690Why did this record match?
Applicant Name (Manufacturer) :
BESMED HEALTH BUSINESS CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Besmed Volumetric Incentive Spirometer is intended as an inspiratory deep breathing positive exerciser. Intended for single-patient, multi-use in a hospital or home care setting.
Device Description
The Besmed Volumetric Incentive Spirometer has a flexible tube and mouthpiece which the patient inhales through. This tube connects to the inspiration port of the unit. The chamber has a ball and piston which upon the patient inhaling, creates a vacuum, which causes the ball and piston to rise, the piston reflects the inspiratory volume while the ball is an indicator for the user to maintain the optimum inspiratory flow rate. Two (2) models are offered - 2500 cc and 5000 cc. It is a single patient, multi-use, disposable, non-sterile device. The mouthpiece may be removed and cleaned by the user as needed but the main device is not to be cleaned.
As a patient improves their respiratory capacity or gets stronger they improve their inspiratory volume raising the piston. The principle of the ball indicator is to provide the user a visual indicator of their inspiratory flow rate and help them to improve the respiratory function with repeated uses. Incentive spirometers are commonly referred to as "lung exercisers".
The Besmed Volumetric ICS achieves the therapeutic intent by helping the patient to improve their inspiratory volume. It is a relative improvement device that as described offers the patient the "incentive" to improve. This is the identical therapeutic intent of the predicate volume based incentive spirometer.
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