The following data is part of a premarket notification filed by Artec Environmental Monitoring Division with the FDA for The Carolina Rocker.
| Device ID | K900839 |
| 510k Number | K900839 |
| Device Name: | THE CAROLINA ROCKER |
| Classification | Components, Wheelchair |
| Applicant | ARTEC ENVIRONMENTAL MONITORING DIVISION 110 STONEHEDGE DR. Greenville, SC 29615 |
| Contact | Randolph E Crew |
| Correspondent | Randolph E Crew ARTEC ENVIRONMENTAL MONITORING DIVISION 110 STONEHEDGE DR. Greenville, SC 29615 |
| Product Code | KNN |
| CFR Regulation Number | 890.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-22 |
| Decision Date | 1990-04-18 |