FDA.reportPublic FDA data

ClearChest®

Primary DI
00841561102174
Brand
ClearChest®
Company
Respiratory Technologies, Inc.
Model
100134-000
Device description
Comfort Vest, Size 34
Published
2016-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K051383000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051383000THE INCOURAGE SYSTEMRespiratory Technologies, Incorporated2005-06-17BYI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841561102174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841561102174008415611021748415611021740841561102174

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Circumference34Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-793-1261xx@xx.xx

Regulatory Flags#

DUNS number
847990566
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00606959420540inCourage®ICS-1M-US-AR500055-0002025-09-17
00606959420557inCourage®ICS-1M-US-AR500055-0012025-09-17
00606959420564inCourage®ICS-1M-US-AR500055-0112025-09-17
00606959420571inCourage®ICS-1M-US-AR500055-0112025-09-17
00841561100279inCourage®100022-0002016-09-10
00841561102754inCourage®500040-0002016-09-10
00841561102792inCourage®500040-0012016-12-21
00841561100217inCourage®100020-0032016-09-10
00841561100682inCourage®100030-0052016-09-10
00841561100712inCourage®100030-0082016-09-10
00841561101122inCourage®100040-0032016-09-10
00841561101139inCourage®100040-0042016-09-10
00841561101146inCourage®100040-0052016-09-10
00841561101252inCourage®100042-0072016-09-10
00841561101269inCourage®100042-0082016-09-10
00841561101276inCourage®100044-0002016-09-10
00841561101290inCourage®100044-0022016-09-10
00841561101382inCourage®100046-0022016-09-10
00841561101399inCourage®100046-0032016-09-10
00841561101405inCourage®100046-0042016-09-10

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
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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