FDA.reportPublic FDA data

SmartVest

Primary DI
B102125003S1200
Brand
SmartVest
Company
ELECTROMED, INC.
Model
SmartVest
Catalog number
125003-S-120
Device description
SmartVest® - Airway Clearance System (ACS)
Published
2026-10-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
B102125003S1200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Chest-oscillation airway secretion-clearing system generatorA mains electricity (AC-powered) component of a high frequency chest wall oscillation airway secretion-clearing system intended to produce oscillating pressurized air-pulses that are delivered to an inflatable vest via a dedicated thick-walled hose. The air-pulses cause the vest to rapidly inflate and deflate against the chest wall of the patient promoting airway clearance by creating high frequency chest wall oscillation (HFCWO) resulting in the mobilization of bronchial secretions.

Regulatory Flags#

DUNS number
036514250
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
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