SmartVest - SQL® SmartVest® ACS - ELECTROMED, INC.

Duns Number:036514250

Device Description: SQL® SmartVest® ACS

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More Product Details

Catalog Number

SQL

Brand Name

SmartVest

Version/Model Number

SQL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K132794

Product Code Details

Product Code

BYI

Product Code Name

Percussor, Powered-Electric

Device Record Status

Public Device Record Key

300d777f-7723-46d3-b680-1faee9750622

Public Version Date

December 11, 2019

Public Version Number

4

DI Record Publish Date

June 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ELECTROMED, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 158