Air Flex with Auto-Distraction

Basic Information

• Brand Name: Air Flex with Auto-Distraction
• Primary DI: 00860001452525
• Version / Model: Air Flex II with Auto-Distraction
• Company Name: HILL LABORATORIES CO.
• Labeler DUNS: 002326585
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-04
• Public Version: 1
• Public Version Date: 2020-02-12
• Public Version Status: New
• Public Device Record Key: 65b9d0d7-672d-45bd-9935-5609c7e1dc20

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JFB	Table, Physical Therapy, Multi Function	Physical Medicine	890.5880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860001452525	GS1

Premarket Submissions

Submission Number	Supplement Number
K063034	000