Catalog Number

-

Brand Name

Homedics

Version/Model Number

SP-104HJ

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)

-

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

8f14f9f0-896c-4ca6-9d72-8839b20d6914

Public Version Date

June 23, 2021

Public Version Number

1

DI Record Publish Date

June 15, 2021

Package DI Number

10031262102635

Quantity per Package

3

Contains DI Package

00031262102638

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-