Tilt Seating System
FDA 510(k) K923366 · Labac Systems, Inc.
510(k) numberK923366
Submission
- Device name
- Tilt Seating System
- Applicant
- Labac Systems, Inc.
Highlands Ranch, CO, US - Received
- July 8, 1992
- Decision date
- February 12, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KNN – Components, Wheelchair
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3920
- Specialty
- Physical Medicine
Other 510(k)s with product code KNN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K211919 | KISS Dynamic Back Support, KISS Dynamic Solid Drop SeatKNN · Traditional | Kinetic Innovative Seating System, LLC | 03/04/2022SE |
| K942311 | Dynasty U1-33 AgmKNN · Traditional | Foley & Lardner | 11/07/1994SE |
| K942310 | Dynasty GC 12550 (Gell/Cell)KNN · Traditional | Foley & Lardner | 11/07/1994SE |
| K942309 | Dynasty U1-31 (Gell/Cell)KNN · Traditional | Foley & Lardner | 11/07/1994SE |
| K942308 | Dynasty GC 12400 (Gell/Cell)KNN · Traditional | Foley & Lardner | 11/07/1994SE |
| K942312 | Alden Lineage Wheelchair CushionKNN · Traditional | Lewis W. Ward | 05/26/1994SE |
| K942260 | Alden Wheelchair CushionKNN · Traditional | Ward and Assoc. | 05/26/1994SE |
| K933051 | Zero Gravity Wheelchair Components, ModificationKNN · Traditional | General Components Intl., Inc. | 10/12/1993SE |
| K925980 | PMKNN · Traditional | Pathfinder Intl. Corp. | 03/24/1993SE |
| K923942 | Rhombo Medical Rhombo-FillKNN · Traditional | International Medical Products, Inc. | 03/24/1993SE |
More from International Medical Products, 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 |
| K923363 | Adjustable Sliding Back Power Recline SystemITI · Traditional | 03/24/1993SE |
| 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 |
| K921136 | Manual Tilt ChairIOR · Traditional | 04/02/1992SE |
| K921027 | Manual Chair BaseKNN · Traditional | 03/20/1992SE |
Questions and answers
When was Tilt Seating System cleared by the FDA?
Tilt Seating System (K923366) received a 510(k) decision of Substantially Equivalent on February 12, 1993, 219 days after the submission was received.
What is the product code of K923366?
The FDA product code is KNN – Components, Wheelchair, a Class I (low risk) device regulated under 21 CFR 890.3920.