Tilt/Reduced Shear Semi-recline Seating System
by Labsystems, Inc. 510(k)
Active
510(k) K923365
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK923365 | Date24 Mar 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- ITI
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3860
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Tilt/Reduced Shear Semi-recline Seating System is a medical device classified as a wheelchair, powered. It is designed to provide seating with tilt and reduced shear capabilities in a semi-recline position.
This device is manufactured by Labsystems, Inc. and received FDA 510(k) clearance on March 24, 1993, with K number K923365. It is classified as a class 2 medical device under product code ITI and is intended for use in physical medicine applications.