T-2000-Power Tilt Seating System, Models Ard-Tstorm, Ard-Tp-320, Ard-TG424, Ard-TS525, Ard-Tjazzy, Ard-Tlancer
by Accelerated Rehab Designs, Inc.
510(k) K992804
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992804 | Date3 Feb 2000 | 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- Withdrawn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
- ITI
- Models / Variants
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3860
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The T-2000 Power Tilt Seating System is a powered wheelchair designed for adjustable seating and positioning. It incorporates tilt mechanisms to facilitate changes in user posture, promoting comfort and reducing pressure injuries during prolonged use.
This system is intended for clinical use in physical medicine settings and is supplied as a reusable medical device. Each model (ARD-TSTORM, ARD-TP-320, ARD-TG424, ARD-TS525, ARD-TJAZZY, ARD-TLANCER) is classified as a Class II device under FDA regulations (890.3860) and holds a 510(k) clearance (K992804). No specific sterility or MRI safety information is provided in the data.
Other devices from Accelerated Rehab Designs, Inc.
Questions
AI-generated answers, 19 Sep 2026
What clinical settings is the T-2000 Power Tilt Seating System primarily intended for use in?
The T-2000 Power Tilt Seating System is designed for use in physical medicine settings, such as rehabilitation clinics, therapy centers, or specialized care facilities where adjustable seating and positioning are critical for patient comfort and mobility management.
Are the different models (ARD-TSTORM, ARD-TP-320, etc.) interchangeable, or do they serve distinct purposes?
The models listed (ARD-TSTORM, ARD-TP-320, ARD-TG424, ARD-TS525, ARD-TJAZZY, ARD-TLANCER) are separate configurations of the T-2000 Power Tilt Seating System, each likely tailored to different patient needs or seating requirements. While they share core tilt functionality, their specific design features (e.g., frame size, motor power, or seating adjustments) may vary to accommodate diverse clinical applications.
Is this device single-use or reusable, and what does that mean for maintenance?
The T-2000 Power Tilt Seating System is classified as a reusable medical device. This means it is intended for repeated use across multiple patients, provided it undergoes proper cleaning, disinfection, and maintenance as outlined in the manufacturer’s instructions to ensure safety and functionality.
How is the regulatory pathway for this device described, and what does that imply for buyers?
The device holds a 510(k) clearance (K992804) under FDA regulations, classified as a Class II medical device (890.3860) with a substantially equivalent determination. This implies the device has been reviewed by the FDA’s Physical Medicine (PM) advisory committee and meets established safety and performance standards for powered wheelchairs with tilt mechanisms, ensuring it complies with U.S. regulatory requirements for clinical use.
Are there any special considerations for storage or handling of this device?
The provided data does not specify sterility requirements or MRI safety information for the T-2000 Power Tilt Seating System. However, as a reusable medical device, proper storage in a clean, dry environment—protected from dust, moisture, and physical damage—is recommended to maintain functionality and hygiene. Always follow the manufacturer’s guidelines for setup, maintenance, and cleaning protocols.