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AffloVest

Movair, Inc. · Model 8300 · UDI-DI 00814321020063

BYI Prescription

510(k) clearances

283

Adverse events (6 deaths)

Recalls

Facilities

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.

Recalls

Date	Firm	Reason
2021-03-31	Smiths Medical ASD Inc.	The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.
2017-09-15	HILL-ROM MANUFACTURING, INC.	Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or implantable cardioverter defibrillators as well as other devices that might be subje
2014-11-13	Aptalis Pharmatech Inc.	Customer notification that the device may be difficult to open or close.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.