FDA.reportPublic FDA data

inCourage®

Primary DI
00606959420571
Brand
inCourage®
Company
Respiratory Technologies, Inc.
Model
ICS-1M-US-A
Catalog number
R500055-011
Device description
Pulsating Therapy Unit
Published
2025-09-17
Public version status
New
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
00606959420571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00606959420571006069594205716069594205710606959420571

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-28 Degrees Celsius85 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
847990566
Device count
1
Serial number
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
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
00841561102174ClearChest®100134-0002016-09-10

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
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