Dynasty GC 12550 (Gell/Cell)
FDA 510(k) K942310 · Foley & Lardner
510(k) numberK942310
Submission
- Device name
- Dynasty GC 12550 (Gell/Cell)
- Applicant
- Foley & Lardner
Washington, DC, US - Received
- May 13, 1994
- Decision date
- November 7, 1994
- 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 |
| 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 |
| K923364 | Tilt Adjustable Sliding Back Recline Seating SystKNN · Traditional | Labac Systems, Inc. | 03/22/1993SE |
More from Labac Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K973613 | CH-611B and CH-611C Digital Wrist Sphygmomanometers Blood Pressure MeterDXN · Traditional | 04/14/1998SE |
| K942311 | Dynasty U1-33 AgmKNN · Traditional | 11/07/1994SE |
| K942309 | Dynasty U1-31 (Gell/Cell)KNN · Traditional | 11/07/1994SE |
| K942308 | Dynasty GC 12400 (Gell/Cell)KNN · Traditional | 11/07/1994SE |
Questions and answers
When was Dynasty GC 12550 (Gell/Cell) cleared by the FDA?
Dynasty GC 12550 (Gell/Cell) (K942310) received a 510(k) decision of Substantially Equivalent on November 7, 1994, 178 days after the submission was received.
What is the product code of K942310?
The FDA product code is KNN – Components, Wheelchair, a Class I (low risk) device regulated under 21 CFR 890.3920.