DR-HO'S - Decompression BeltThis product is used for - Guangzhou Xinbo Electronic Co., Ltd.

Duns Number:530683813

Device Description: Decompression BeltThis product is used for external fixation of the waist and longitudinal Decompression BeltThis product is used for external fixation of the waist and longitudinal traction of the lumbar spine.It is composed by traction belt and air pump

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More Product Details

Catalog Number

-

Brand Name

DR-HO'S

Version/Model Number

Size A/B

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

HST

Product Code Name

Apparatus, Traction, Non-Powered

Device Record Status

Public Device Record Key

c13a0cee-7b18-435e-81cb-2f46b564e6a4

Public Version Date

August 20, 2020

Public Version Number

2

DI Record Publish Date

March 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GUANGZHOU XINBO ELECTRONIC CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13
2 A medical device with a moderate to high risk that requires special controls. 26