Traction 230
510(k) K830088
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK830088 | Date24 Jan 1983 | 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- Withdrawn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, 1 Oct 2026
Equipment, Traction, Powered is a device used to apply a pulling force to the body for therapeutic purposes. It is designed to provide mechanical traction for the treatment of musculoskeletal conditions.
This device is supplied as reusable equipment and is intended for use in clinical settings such as physical medicine departments. It has received FDA 510(k) clearance under product code ITH and regulation number 890.5900, with a decision of substantially equivalent granted on January 24, 1983.
Other devices from Tri W-G, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the TRACTION 230 used for?
The TRACTION 230 is a powered traction device designed to apply a pulling force to the body for therapeutic purposes, specifically to provide mechanical traction for the treatment of musculoskeletal conditions in clinical settings such as physical medicine departments.
Is the TRACTION 230 reusable or single-use?
The TRACTION 230 is supplied as reusable equipment, meaning it is intended for multiple uses after appropriate cleaning and maintenance, as indicated in its device description and regulatory documentation.
What regulatory pathway was used for the TRACTION 230?
The TRACTION 230 received FDA 510(k) clearance under submission K830088, with a determination of substantial equivalence granted on January 24, 1983, based on its similarity to a legally marketed predicate device.