Adjustable Sliding Back Power Recline System
FDA 510(k) K923363 · Labac Systems, Inc.
510(k) numberK923363
Submission
- Device name
- Adjustable Sliding Back Power Recline System
- Applicant
- Labac Systems, Inc.
Highlands Ranch, CO, US - Received
- July 8, 1992
- Decision date
- March 24, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ITI – Wheelchair, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3860
- Specialty
- Physical Medicine
A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets mobility to persons restricted to a sitting position to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility. NOTE: This type…
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| K260335 | Electric Wheelchair (S500-6)ITI · Traditional | Zhongshan Sulenz Intelligent Technology Co., Ltd. | 06/15/2026SE |
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More from Whill, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K941157 | Basic Recline ChairIOR · Traditional | 04/07/1994SE |
| K934418 | Basic Tilt Chair ( BTC )IOR · Traditional | 01/07/1994SE |
| K932639 | Manual Tilt Recline Chair (MTC)IOR · Traditional | 07/22/1993SE |
| K923362 | Reduced Shear Owr Recline SystemITI · Traditional | 03/26/1993SE |
| K921028 | Manual Reclining ChairIOR · Traditional | 03/24/1993SE |
| K923364 | Tilt Adjustable Sliding Back Recline Seating SystKNN · Traditional | 03/22/1993SE |
| K925272 | Pediatric Tilt ChairIOR · Traditional | 02/12/1993SE |
| K923366 | Tilt Seating SystemKNN · Traditional | 02/12/1993SE |
| K921136 | Manual Tilt ChairIOR · Traditional | 04/02/1992SE |
| K921027 | Manual Chair BaseKNN · Traditional | 03/20/1992SE |
Questions and answers
When was Adjustable Sliding Back Power Recline System cleared by the FDA?
Adjustable Sliding Back Power Recline System (K923363) received a 510(k) decision of Substantially Equivalent on March 24, 1993, 259 days after the submission was received.
What is the product code of K923363?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.