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SmartVest

FDA UDI

Class II (US FDA UDI)

by Electromed, Inc.

Identity

Trade Name
SmartVest FDA UDI
Generic Name
Chest-oscillation airway secretion-clearing system vest FDA UDI
Device Name
Refurbished SQL® SmartVest® ACS FDA UDI
Model / Reference
SQL_R FDA UDI
Description
Refurbished SQL® SmartVest® ACS FDA UDI

Identifiers

Catalog Number
SQL_R FDA UDI
Primary DI / UDI-DI
B102090488S0110 FDA UDI
510(k) Number
K132794 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Chest-oscillation airway secretion-clearing system vest

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 vest.

Cleared under the same submission

K132794 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Electromed, Inc.

Sources (1)

  • FDA UDI cb4b7f70-7161-4298-a61f-d04c799e8e36 35 fields · synced May 30, 2026