Catalog Number

-

Brand Name

HOMEDICS

Version/Model Number

SP-129HJ

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

a32ad175-f05b-4abb-b576-0cd54f8dddec

Public Version Date

September 08, 2020

Public Version Number

1

DI Record Publish Date

August 31, 2020

Package DI Number

10031262089196

Quantity per Package

4

Contains DI Package

00031262089199

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case