Catalog Number

-

Brand Name

Bio Protech

Version/Model Number

MaxEMS 1k

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"

Yes

For Single-Use

Yes

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

K091248,K091248,K091248

Product Code

IPF

Product Code Name

Stimulator, Muscle, Powered

Public Device Record Key

4d397ad5-e52c-4611-ad63-2a7787d32fee

Public Version Date

February 19, 2021

Public Version Number

8

DI Record Publish Date

June 16, 2016

Package DI Number

20817120020078

Quantity per Package

8

Contains DI Package

10817120020071

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case