VAX-D Genesis G2 System
by Vax-D Medical Technologies, LLC 510(k)
Active
510(k) K071347
Overview
The VAX-D Genesis G2 System is a powered traction device designed for spinal decompression, applying distraction tensions to the lumbar and cervical spine. It incorporates principles from predicate devices including the VAX-D Genesis System, VAX-D Therapeutic Table, 3D Activetrac, and Henley Tru-Trac 401.
The system is used with a patient lying on a split table, with the upper body restrained by handgrips or passive shoulder restraints. It is designed to be movable between rooms and upgradeable at the touch of a button. The device has FDA 510(k) clearance with product code ITH and is classified as Class II medical equipment for physical medicine.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK071347 | Date5 Oct 2007 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- ITH
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5900
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the VAX-D Genesis G2 System designed for?
The VAX-D Genesis G2 System is a powered traction device designed for spinal decompression, applying distraction tensions to the lumbar and cervical spine. It incorporates principles from predicate devices including the VAX-D Genesis System, VAX-D Therapeutic Table, 3D Activetrac, and Henley Tru-Trac 401.
How is the VAX-D Genesis G2 System used with patients?
The system is used with a patient lying on a split table, with the upper body restrained by handgrips or passive shoulder restraints. It is designed to be movable between rooms and upgradeable at the touch of a button.
What is the regulatory classification of the VAX-D Genesis G2 System?
The device has FDA 510(k) clearance with product code ITH and is classified as Class II medical equipment for physical medicine. It received FDA clearance on October 5, 2007.
Is the VAX-D Genesis G2 System cleared for specific medical indications?
The device is cleared as substantially equivalent to predicate devices for spinal decompression, applying distraction tensions to the lumbar and cervical spine. The advisory committee review was for Physical Medicine.