Homedics - Neck Massager - Electrical Appliance Branch of Zhangzhou Easepal Industrial Corporation

Duns Number:544372391

Device Description: Neck Massager

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More Product Details

Catalog Number

-

Brand Name

Homedics

Version/Model Number

NMS-390HJ

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)

Yes

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

69a01f47-d7e0-4e58-8f43-9f1bacc39331

Public Version Date

June 23, 2022

Public Version Number

1

DI Record Publish Date

June 15, 2022

Additional Identifiers

Package DI Number

10031262106978

Quantity per Package

3

Contains DI Package

00031262106971

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"ELECTRICAL APPLIANCE BRANCH OF ZHANGZHOU EASEPAL INDUSTRIAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7