Identity
- Trade Name
- inCourage® FDA UDI
- Generic Name
- Chest-oscillation airway secretion-clearing system vest FDA UDI
- Device Name
- Vest, Size 18, Flower Power FDA UDI
- Model / Reference
- 100018-004 FDA UDI
- Description
- Vest, Size 18, Flower Power FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841561100132 FDA UDI
- 510(k) Number
- K051383 FDA UDI
- FDA Product Code
- BYI FDA UDI
- GMDN Term
- Chest-oscillation airway secretion-clearing system vest FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5665 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Circumference — 18 Inch FDA UDI
Category: Chest-oscillation airway secretion-clearing system vest
inCourage® by Respiratory Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Chest-oscillation airway secretion-clearing system vest.
- SmartVest — Electromed, Inc. · Class II
- SmartVest — Electromed, Inc. · Class II
- SmartVest — Electromed, Inc. · Class II
- SmartVest — Electromed, Inc. · Class II
- SmartVest — Electromed, Inc. · Class II
- SmartVest — Electromed, Inc. · Class II
- SmartVest — Electromed, Inc. · Class II
- SmartVest — Electromed, Inc. · Class II
Cleared under the same submission
K051383 also covers:
- ClearChest® — RESPIRATORY TECHNOLOGIES, INC.
- ClearChest® — RESPIRATORY TECHNOLOGIES, INC.
- ClearChest® — RESPIRATORY TECHNOLOGIES, INC.
- ClearChest® — RESPIRATORY TECHNOLOGIES, INC.
- ClearChest® — RESPIRATORY TECHNOLOGIES, INC.
- ClearChest® — RESPIRATORY TECHNOLOGIES, INC.
- InCourage® — RESPIRATORY TECHNOLOGIES, INC.
- InCourage® — RESPIRATORY TECHNOLOGIES, INC.
- InCourage® — RESPIRATORY TECHNOLOGIES, INC.
- InCourage® — RESPIRATORY TECHNOLOGIES, INC.
- inCourage® — RESPIRATORY TECHNOLOGIES, INC.
- inCourage® — RESPIRATORY TECHNOLOGIES, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Respiratory Technologies, Inc.
Sources (1)
- FDA UDI b672bade-991c-4e6a-9de4-ba96c96aca75 36 fields · synced Jun 8, 2026