Catalog Number

SV2100-TWN

Brand Name

SmartVest

Version/Model Number

SV2100-TWN

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

K053248

Product Code

BYI

Product Code Name

Percussor, Powered-Electric

Public Device Record Key

6f03a1f0-b10c-4f28-8fde-18e9de1bb29f

Public Version Date

December 11, 2019

Public Version Number

4

DI Record Publish Date

March 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-