The following data is part of a premarket notification filed by Medco Products, Co., Inc. with the FDA for Jyrochair, Model Sk-h.
| Device ID | K852015 |
| 510k Number | K852015 |
| Device Name: | JYROCHAIR, MODEL SK-H |
| Classification | Wheelchair, Powered |
| Applicant | MEDCO PRODUCTS, CO., INC. 31 PARK RD. P.O. BOX E Tinton Falls, NJ 07724 |
| Contact | Richard N Lord |
| Correspondent | Richard N Lord MEDCO PRODUCTS, CO., INC. 31 PARK RD. P.O. BOX E Tinton Falls, NJ 07724 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-09 |
| Decision Date | 1985-07-19 |