Catalog Number

SQL-I_R

Brand Name

SmartVest

Version/Model Number

SQL-I_R

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

BYI

Product Code Name

Percussor, Powered-Electric

Public Device Record Key

3cd8b763-3f1e-4eb3-9cac-019d2b362141

Public Version Date

December 11, 2019

Public Version Number

3

DI Record Publish Date

May 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-