FDA.reportPublic FDA data

SmartVest

Primary DI
B102060710S2160
Brand
SmartVest
Company
ELECTROMED, INC.
Model
SV-40-AM-PC
Catalog number
SV-40-AM-PC
Device description
LTU SmartVest® – Adult Medium (PK Camo)
Published
2016-09-23
Public version status
Update
Distribution status
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B102060710S2160PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Chest-oscillation airway secretion-clearing system vestA tightly-fitting garment-like device that is a component of a high frequency chest wall oscillation airway secretion-clearing system and which is designed to be worn by a patient to encompass the thorax during high frequency chest wall oscillation (HFCWO) treatment. It is connected via a dedicated thick-walled hose to the system's generator which rapidly inflates and deflates the vest against the chest wall to promote airway clearance by creating HFCWO resulting in the mobilization of bronchial secretions. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
036514250
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B102090700S0100SmartVestSMARTVEST-HSSMARTVEST-HS2025-07-02
B102125003S0110SmartVestClearway-HOR125003-S-0112025-03-19
B102125003S0311SmartVestClearway Demo125003-S-0312025-01-21
B102125003S0411SmartVestClearway Eval125003-S-0412025-01-21
B102090170S0100SmartVestSMARTVEST-ORSMARTVEST-OR2023-07-31
B102125003S0210SmartvestClearway-IRClearway-IR2023-07-05
B102125011S0100SmartVestCLEARWAY-PEDCLEARWAY-PED2023-07-05
B102125003S0100SmartvestClearway Air Pulse GeneratorClearway HOM2023-02-17
B102125003S0200SmartvestClearway-I Air Pulse GeneratorClearway-I2023-02-17
B102090683S0100SmartVestSQL-PEDESTALSQL-PEDESTAL2016-09-16
B102090766S0100SmartVestSQL-FOOT-KITSQL-FOOT-KIT2019-03-28
B102060078S0030SmartVestSV-20-SS-GKSV-20-SS-GK2016-06-30
B102060078S0040SmartVestSV-20-SS-PKSV-20-SS-PK2016-09-16
B102060078S0050SmartVestSV-20-SSSV-20-SS2016-09-16
B102060078S0060SmartVestSV-20-SS-YLSV-20-SS-YL2016-09-16
B102060078S0070SmartVestSV-20-SS-PPSV-20-SS-PP2016-09-16
B102060078S0080SmartVestSV-20-SS-RDSV-20-SS-RD2016-09-16
B102060078S0090SmartVestSV-20-SS-BUSV-20-SS-BU2016-09-16
B102060078S0100SmartVestSV-24-CSSV-24-CS2016-09-16
B102060078S0110SmartVestSV-24-CS-YLSV-24-CS-YL2016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07290020062000LibAirty Airway Clearance SystemSYNCHRONY MEDICAL LTDBYI2025-05-19
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
00887761976849The Vest®SystemHILL-ROM SERVICES PTE. LTD.BYI2024-12-20
00887761967243The Vest APX SystemHILL-ROM SERVICES PTE. LTD.BYI2024-09-06
00887761967366The Vest APX SystemHILL-ROM SERVICES PTE. LTD.BYI2024-09-06
00887761967373The Vest APX SystemHILL-ROM SERVICES PTE. LTD.BYI2024-09-06
B99893699980215050AirPhysioAIRPHYSIO PTY. LTD.BYI2024-01-22