Homedics - THERA-P BODY MASSAGER WITH - Health Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd.

Duns Number:544356011

Device Description: THERA-P BODY MASSAGER WITH

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More Product Details

Catalog Number

-

Brand Name

Homedics

Version/Model Number

HHP-110J-CVS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

ISA

Product Code Name

Massager, Therapeutic, Electric

Device Record Status

Public Device Record Key

0da8c415-fed3-4d34-b68a-6b0974252078

Public Version Date

August 20, 2020

Public Version Number

2

DI Record Publish Date

June 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HEALTH CARE MASSAGE BRANCH OF ZHANGZHOU EASEPAL INDUSTRIAL CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 61