Catalog Number

-

Brand Name

BiowavePRO

Version/Model Number

BWPD01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K061166

Product Code

NHI

Product Code Name

Stimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief

Public Device Record Key

2a4c34b5-7643-4bf2-9c60-fc67ae204dfc

Public Version Date

January 08, 2021

Public Version Number

5

DI Record Publish Date

August 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-