FDA.reportPublic FDA data

SmartVest

Primary DI
B10209488S1510
Brand
SmartVest
Company
ELECTROMED, INC.
Model
SQL_R-W-RD
Catalog number
SQL_R-W-RD
Device description
Refurb SQL® SmartVest®, Wireless (Red)
Published
2017-07-18
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132794000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132794000SMARTVEST AIRWAY CLEARANCE SYSTEMElectromed, Inc.2013-12-19BYI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B10209488S1510PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
036514250
Device count
1
Serial number
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
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