Bass Antalgic-Trak
510(k) K042482
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK042482 | Date21 Mar 2005 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 24 Sep 2026
The Bass Antalgic-Trak is a multi-functional, chair-like powered traction table that accommodates patients in sitting or reclined positions up to 90 degrees. It maintains the patient's sitting posture during recline and allows for clinician-set parameters via a control panel.
This device is supplied as a non-sterile, reusable medical device used in physical medicine settings. It is FDA 510(k) cleared with product code ITH and device class 2, manufactured by Traction Masters, LLC. The device is designed for powered traction applications in clinical environments.
Questions
AI-generated answers, 24 Sep 2026
What is the Bass Antalgic-Trak used for?
The Bass Antalgic-Trak is a multi-functional, chair-like powered traction table designed for physical medicine settings. It accommodates patients in sitting or reclined positions up to 90 degrees while maintaining sitting posture during recline, allowing for clinician-set parameters via a control panel.
How is the Bass Antalgic-Trak supplied and is it reusable?
The device is supplied as a non-sterile, reusable medical device intended for use in clinical environments. It is designed for powered traction applications and can be used multiple times with proper cleaning and maintenance according to manufacturer guidelines.
What are the regulatory specifications of the Bass Antalgic-Trak?
The Bass Antalgic-Trak is FDA 510(k) cleared with product code ITH and device class 2. It received traditional clearance on March 21, 2005, with decision code SESE, indicating it is substantially equivalent to predicate devices in the physical medicine advisory committee category.
What are the key features of the Bass Antalgic-Trak?
The device maintains patient sitting posture during recline and allows for clinician-set parameters via a control panel. It is designed for powered traction applications in clinical environments, accommodating patients in various positions up to 90 degrees.