Catalog Number

420100

Brand Name

BEMER Therapy Systems

Version/Model Number

B.BOX Classic

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

ISA

Product Code Name

Massager, Therapeutic, Electric

Public Device Record Key

cb9f52c6-a602-458a-875e-4802929561a5

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 03, 2017

Package DI Number

07640161461017

Quantity per Package

1

Contains DI Package

07640161462014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-