FDA.reportPublic FDA data

AffloVest

Primary DI
00814321020087
Brand
AffloVest
Company
Movair, Inc.
Model
8300XXL
Device description
The AffloVest is comprised of a vest of synthetic polymer fabric with oscillating vibratory motorsorganized 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 bronchialdrainage by enhancing mobilization of bronchial secretions where external manipulation of thethorax is the physician’s choice of treatment.
Published
2015-11-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BYIPercussor, Powered-Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYIPercussor, Powered-ElectricAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122480000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122480000INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVESTInternational Biophysics Corporation2013-03-27BYI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814321020087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814321020087008143210200878143210200870814321020087

GMDN Terms#

Term, Definition table
TermDefinition
Chest-oscillation airway secretion-clearing systemAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
788403103
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013561406MPVMV50012025-03-12
00860013561413MPVMV50002025-03-12
10814321020152"FloProbe 1/4’’ x 1/4"" (Non Sterile)"3090N2016-07-12
10814321020176FloProbe 3/8’’ x 3/8” (Non Sterile)3080N 2016-07-12
10814321020213IBC Aortic Punch, Long, 2.8mmAPL282016-08-02
10814321020220IBC Aortic Punch, Long, 3.6mmAPL36 2016-08-02
10814321020237IBC Aortic Punch, Long, 4.0mmAPL402016-08-02
10814321020244IBC Aortic Punch, Long, 4.4mmAPL442016-08-02
10814321020251IBC Aortic Punch, Long, 4.8mmAPL482016-08-02
10814321020268IBC Aortic Punch, Long, 5.2mmAPL522016-08-02
10814321020275IBC Aortic Punch, Long, 5.6mmAPL562016-08-02
10814321020282IBC Aortic Punch, Long, 6.0mmAPL602016-08-02
10814321020299IBC Aortic Punch, Medium, 2.8mmAPM282016-08-02
10814321020305IBC Aortic Punch, Medium, 3.6mmAPM362016-08-02
10814321020312IBC Aortic Punch, Medium, 4.0mmAPM402016-08-02
10814321020329IBC Aortic Punch, Medium, 4.4mmAPM442016-08-02
10814321020336IBC Aortic Punch, Medium, 4.8mmAPM482016-08-02
10814321020343IBC Aortic Punch, Medium, 5.2mmAPM522016-08-02
10814321020350IBC Aortic Punch, Medium, 5.6mmAPM562016-08-02
10814321020367IBC Aortic Punch, Medium, 6.0mmAPM602016-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841470100841PercussorPULMODYNE INCBYI2026-05-29
00841470100858PercussorPULMODYNE INCBYI2026-05-29
00816305024890AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305024906AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305024913AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305024920AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305024937AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025101AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025248AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025255AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025262AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025279AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025286AffloVestTactile Systems Technology, Inc.BYI2026-05-27
10889483563113BALLARD™SUNMED, LLCBYI2025-12-01
30889483563117BALLARD™SUNMED, LLCBYI2025-12-01
00606959420540inCourage®Respiratory Technologies, Inc.BYI2025-09-17
00606959420557inCourage®Respiratory Technologies, Inc.BYI2025-09-17
00606959420564inCourage®Respiratory Technologies, Inc.BYI2025-09-17
00606959420571inCourage®Respiratory Technologies, Inc.BYI2025-09-17
B102090700S0100SmartVestELECTROMED, INC.BYI2025-07-02
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07290020062017LibAirty Airway Clearance System Vest (S)SYNCHRONY MEDICAL LTDBYI2025-05-19
07290020062024LibAirty Airway Clearance System Vest (M)SYNCHRONY MEDICAL LTDBYI2025-05-19
07290020062031LibAirty Airway Clearance System Vest (L)SYNCHRONY MEDICAL LTDBYI2025-05-19
B102125003S0110SmartVestELECTROMED, INC.BYI2025-03-19
B102125003S0311SmartVestELECTROMED, INC.BYI2025-01-21
B102125003S0411SmartVestELECTROMED, INC.BYI2025-01-21
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