The Carolina Rocker
FDA 510(k) K900839 · Artec Environmental Monitoring Division
510(k) numberK900839
Submission
- Device name
- The Carolina Rocker
- Applicant
- Artec Environmental Monitoring Division
Greenville, SC, US - Received
- February 22, 1990
- Decision date
- April 18, 1990
- 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 |
|---|---|---|
| K896886 | Artec Respond Pulmonary ResuscitatorBTM · Traditional | 02/06/1990SE |
| K873043 | Mouth to Face ResuscitatorBTM · Traditional | 09/28/1987SE |
| K863910 | RaincoatBZO · Traditional | 10/20/1986SE |
| K854573 | Anesthesia Shutoff Valve Positive ClosureCAI · Traditional | 01/03/1986SE |
| K832512 | Airway MasksCAE · Traditional | 01/17/1984SE |
| K830056 | Artec Twist ValveBTC · Traditional | 03/09/1983SE |
Questions and answers
When was The Carolina Rocker cleared by the FDA?
The Carolina Rocker (K900839) received a 510(k) decision of Substantially Equivalent on April 18, 1990, 55 days after the submission was received.
What is the product code of K900839?
The FDA product code is KNN – Components, Wheelchair, a Class I (low risk) device regulated under 21 CFR 890.3920.