Upholstered Bucket Seat
FDA 510(k) K862887 · Mednet, Inc.
510(k) numberK862887
Submission
- Device name
- Upholstered Bucket Seat
- Applicant
- Mednet, Inc.
Battle Creek, MI, US - Received
- July 22, 1986
- Decision date
- August 14, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K955782 | Med-Net StopcocksFMG · Traditional | 02/21/1996SE |
| K862892 | Caster CarIOR · Traditional | 08/14/1986SE |
| K862885 | Car SeatINN · Traditional | 08/14/1986SE |
| K862883 | Orthopedic SeatsINN · Traditional | 08/14/1986SE |
| K862895 | TricyclesIKX · Traditional | 08/13/1986SE |
| K862894 | SchooltableINW · Traditional | 08/13/1986SE |
| K862893 | Ventral Standing Unit · Traditional | 08/13/1986SE |
| K862890 | Toilet/Shower ChairIOR · Traditional | 08/13/1986SE |
| K862889 | Kiro, Wheelchair for ChildrenIOR · Traditional | 08/13/1986SE |
| K862888 | Perambulator (Stroller)LBE · Traditional | 08/13/1986SE |
Questions and answers
When was Upholstered Bucket Seat cleared by the FDA?
Upholstered Bucket Seat (K862887) received a 510(k) decision of Substantially Equivalent on August 14, 1986, 23 days after the submission was received.
What is the product code of K862887?
The FDA product code is KNN – Components, Wheelchair, a Class I (low risk) device regulated under 21 CFR 890.3920.