The following data is part of a premarket notification filed by Skil-care Corp. with the FDA for Ez On Safety Poncho.
| Device ID | K801489 |
| 510k Number | K801489 |
| Device Name: | EZ ON SAFETY PONCHO |
| Classification | Accessories, Wheelchair |
| Applicant | SKIL-CARE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KNO |
| CFR Regulation Number | 890.3910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-26 |
| Decision Date | 1980-07-14 |