Identity
- Trade Name
- SmartVest FDA UDI
- Generic Name
- Chest-oscillation airway secretion-clearing system generator FDA UDI
- Device Name
- SQL-I Supplement Kit (Italy) FDA UDI
- Model / Reference
- SQL-ITA-I FDA UDI
- Description
- SQL-I Supplement Kit (Italy) FDA UDI
Identifiers
- Catalog Number
- SQL-ITA-I FDA UDI
- Primary DI / UDI-DI
- B102090649S0300 FDA UDI
- 510(k) Number
- K132794 FDA UDI
- FDA Product Code
- BYI FDA UDI
- GMDN Term
- Chest-oscillation airway secretion-clearing system generator 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Chest-oscillation airway secretion-clearing system generator
SmartVest by Electromed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Chest-oscillation airway secretion-clearing system generator.
- inCourage® — RESPIRATORY TECHNOLOGIES, INC. · Class II
- inCourage® — RESPIRATORY TECHNOLOGIES, INC. · Class II
- inCourage® — RESPIRATORY TECHNOLOGIES, INC. · Class II
- inCourage® — RESPIRATORY TECHNOLOGIES, INC. · Class II
- inCourage® — RESPIRATORY TECHNOLOGIES, INC. · Class II
- inCourage® — RESPIRATORY TECHNOLOGIES, INC. · Class II
- inCourage® — RESPIRATORY TECHNOLOGIES, INC. · Class II
- SmartVest — Electromed, Inc. · Class II
Cleared under the same submission
K132794 also covers:
- SmartVest — Electromed, Inc.
- SmartVest — Electromed, Inc.
- SmartVest — Electromed, Inc.
- SmartVest — Electromed, Inc.
- SmartVest — Electromed, Inc.
- SmartVest — Electromed, Inc.
- SmartVest — Electromed, Inc.
- SmartVest — Electromed, Inc.
- SmartVest — Electromed, Inc.
- SmartVest — Electromed, Inc.
- SmartVest — Electromed, Inc.
- SmartVest — Electromed, 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
- Electromed, Inc.
Sources (1)
- FDA UDI d41eab80-3b1d-4a6f-a65d-1b849c8a7793 35 fields · synced May 30, 2026