The following data is part of a premarket notification filed by Kaye Products, Inc. with the FDA for Mechanical Chair.
| Device ID | K820591 |
| 510k Number | K820591 |
| Device Name: | MECHANICAL CHAIR |
| Classification | Stroller, Adaptive |
| Applicant | KAYE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LBE |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-04 |
| Decision Date | 1982-03-15 |