510(k) K802642
K802642 is an FDA 510(k) premarket notification submitted by Motion Control, Inc. for the device "UTAH ARTIFICAL ARM". The FDA issued a decision of Substantially Equivalent on November 12, 1980. The device falls under product code IRE (Joint, Elbow, External Limb Component, Powered), a Class I device regulated under 21 CFR 890.3420. Motion Control, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 1980
- Date Received
- October 24, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Joint, Elbow, External Limb Component, Powered
- Device Class
- Class I
- Regulation Number
- 890.3420
- Review Panel
- PM
- Submission Type