SmartVest - SQL-I Supplement Kit (Germany) - ELECTROMED, INC.

Duns Number:036514250

Device Description: SQL-I Supplement Kit (Germany)

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

SQL-DEU-I

Brand Name

SmartVest

Version/Model Number

SQL-DEU-I

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

f495c1f6-d4f8-4f28-83c9-0a5705fb8a69

Public Version Date

December 11, 2019

Public Version Number

4

DI Record Publish Date

March 29, 2017

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