AccessGUDID - DEVICE: Air Flex with Auto-Distraction (00860001452525)

GUDID

Device Identifier (DI) Information

Brand Name: Air Flex with Auto-Distraction
Version or Model: Air Flex II with Auto-Distraction
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HILL LABORATORIES CO.

Primary DI Number: 00860001452525
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002326585 *Terms of Use

Device Description: No description.

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:	Yes
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?
46761	Body arch traction table	A fixed framework table designed to support the body of a patient and provide traction for the back muscles and spine by flexing the patient into a reverse supine body arch. The patient locks their feet behind a cross-member and bends backward over the curvature of the table to flex the vertebrae of the spine, relieving spinal compression, relaxing the shoulders, neck, and back muscles, whilst stretching and strengthening the core muscles of the body. This device can be used in a healthcare facility or in the home to assist patients eliminate/alleviate back pain.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JFB	Table, Physical Therapy, Multi Function

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K063034	000

Device Exempt from Premarket Submission: No 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: 65b9d0d7-672d-45bd-9935-5609c7e1dc20
Public Version Date: February 12, 2020
Public Version Number: 1
DI Record Publish Date: February 04, 2020