Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Acapella Choice Blue Vibratory PEP Device

K-Number: K181660 · 2019-10-24

ApplicantSmiths Medical
Decision Date2019-10-24
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Acapella Choice Blue Vibratory PEP Device is a medical device manufactured by Smiths Medical. It received FDA 510(k) clearance on 2019-10-24 under approval number K181660. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Acapella Choice Blue Vibratory PEP Device?

Acapella Choice Blue Vibratory PEP Device is a medical device that received FDA 510(k) clearance on 2019-10-24. It is manufactured by Smiths Medical. The 510(k) number is K181660.

When was Acapella Choice Blue Vibratory PEP Device approved by the FDA?

Acapella Choice Blue Vibratory PEP Device received FDA 510(k) clearance on 2019-10-24, under approval number K181660.

What company makes Acapella Choice Blue Vibratory PEP Device?

Acapella Choice Blue Vibratory PEP Device is manufactured by Smiths Medical.

What is the FDA product code for Acapella Choice Blue Vibratory PEP Device?

The FDA product code for Acapella Choice Blue Vibratory PEP Device is BWF.

Related Clinical Trials

NCT06099795 Evaluation of Concordance Between Exhaled Air Test (eBAM-CoV) and RT-PCR to Detect SARS-CoV-2 RECRUITING NCT06487273 Long-term Evaluation of the SIMEOX Device at Home in Non-cystic Fibrosis Bronchiectasis RECRUITING NCT07529054 The Potential of Robotic-Assisted Gait Training in a Rehabilitation Setting RECRUITING

Related PubMed Literature

PMID: 32197723 Integrating the Voice of the Patient Into the Medical Device Regulatory Process Using Patient Preference Information. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research (2020)

Related Devices (Code: BWF)

K160636iPEP System and vPEPD R Burton Healthcare, LLC K150044O-PEPPari Respiratory Equipment, Inc. K153441VibraPEPMedica Holdings, LLC K172388VPOD ITPRAdvanced Circulatory System, A Wholly Owned Subsidiary OF K160837MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAMMedinet Srl K163091VibraPEPMedica Holdings, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑