AccessGUDID - DEVICE: DR-HO'S (06970742221497)

GUDID

Device Identifier (DI) Information

Brand Name: DR-HO'S
Version or Model: XB-JT1000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Guangzhou Xinbo Electronic Co., Ltd.

Primary DI Number: 06970742221497
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 530683813 *Terms of Use

Device Description: Neck Comforter This product is used for the peripheral fixation of the neck and the longitudinal traction of the cervical vertebra.It is composed by cloth sleeves, three TPU round air bags and inflatable balls.It is mainly through stretching the cervical interspace under the inflatable state, reducing the pressure of the cervical interspace, improving the burden of the ligaments around the cervical vertebra, so that the injured cervical vertebra can get a full rest.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61203	Wearable cervical spine traction device	An externally-worn orthopaedic device intended to apply traction to the cervical spine/neck to treat pain resulting from non-bone injuries/disorders (e.g., discogenic, occupational, sports, whiplash). It may include moulded components that fit superiorly under the chin and base of the skull, and inferiorly over the base of the neck and collar bone, with rods holding the components apart that can be adjusted to apply traction forces by separation. It is intended for use in the home or a clinical setting. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KQZ	Component, Traction, Non-Invasive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 021a3228-5854-4a26-bdf2-4e99323fa820
Public Version Date: August 20, 2020
Public Version Number: 2
DI Record Publish Date: March 01, 2020