The following data is part of a premarket notification filed by Motion Control, Inc. with the FDA for Utah Artifical Arm.
| Device ID | K802642 |
| 510k Number | K802642 |
| Device Name: | UTAH ARTIFICAL ARM |
| Classification | Joint, Elbow, External Limb Component, Powered |
| Applicant | MOTION CONTROL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IRE |
| CFR Regulation Number | 890.3420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-24 |
| Decision Date | 1980-11-12 |