Catalog Number

-

Brand Name

RENPHO Leg Massager

Version/Model Number

RP-ALM071H

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

K212713,K212713

Product Code

IRP

Product Code Name

Massager, Powered Inflatable Tube

Public Device Record Key

f254d8a2-fd8b-4f05-baae-45f3f9cf11eb

Public Version Date

February 14, 2022

Public Version Number

2

DI Record Publish Date

January 29, 2022

Package DI Number

10850023727074

Quantity per Package

6

Contains DI Package

00850023727077

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-