Reduced Shear OWR Recline System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K923362 ↗

FDA Product Code

ITI

Device Class

Class II

Regulation

21 CFR Part 890.3860

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Manual Tilt Recline Chair (Mtc)

  Class I

  FDA 510(k) K932639 Active Cleared 22 Jul 1993

• Manual Tilt Chair

  Class I

  FDA 510(k) K921136 Active Cleared 2 Apr 1992

• Basic Tilt Chair ( Btc )

  Class I

  FDA 510(k) K934418 Active Cleared 7 Jan 1994

• Tilt Adjustable Sliding Back Recline Seating Syst

  Class I

  FDA 510(k) K923364 Active Cleared 22 Mar 1993

• Pediatric Tilt Chair

  Class I

  FDA 510(k) K925272 Active Cleared 12 Feb 1993

• Tilt Seating System

  Class I

  FDA 510(k) K923366 Active Cleared 12 Feb 1993

See all devices from Labac Systems, Inc. →

• What is the primary purpose of the Reduced Shear OWR Recline System, and how does it benefit users?

  The Reduced Shear OWR Recline System is designed specifically to minimize shear forces on users during reclining movements in powered wheelchairs. By controlling the angle of the seat back relative to the seat surface, it reduces friction and shear stress, which helps lower the risk of pressure-related injuries and improves overall seating comfort for users in both clinical and home settings.

• Is this device intended for single-use or reusable applications, and what storage requirements should be followed?

  The Reduced Shear OWR Recline System is supplied as a reusable medical device. Since it is not sterile out-of-the-box, proper cleaning and maintenance are required between uses. The manufacturer recommends storing it in a clean, dry environment to maintain functionality, though it is not MRI-safe, so magnetic fields should be avoided.

• What regulatory pathway was followed for FDA clearance, and what classification does this device hold?

  The Reduced Shear OWR Recline System received FDA 510(k) clearance under the traditional review pathway, with a decision code of *SESE* (Substantially Equivalent). It is classified as a Class II device under regulation 890.3860, regulated under the *Physical Medicine* specialty, and falls under the ITI product code. No third-party review was required for this submission.

• Are there multiple models or sizes available for this system, and how would I identify the correct one for a patient?

  The Reduced Shear OWR Recline System is associated with multiple FEI numbers (e.g., 3014522447, 3021071770, etc.), which likely correspond to different wheelchair models or configurations. While the exact specifications (e.g., weight capacity, seat dimensions) are not detailed here, these identifiers can be used to cross-reference with the manufacturer’s catalog or technical documentation to ensure compatibility with a patient’s specific wheelchair setup.