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510(k) K802642

UTAH ARTIFICAL ARM by Motion Control, Inc. — Product Code IRE

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

Other clearances by Motion Control, Inc.

  • K872040 — PHORESOR II (TM), MODEL PM700 (August 4, 1987)
  • K862236 — MYOLAB II, MODEL ML-200 (August 7, 1986)
  • K780310 — DERMATRON IONTOPHORESIS DEVICE (July 31, 1978)

Other clearances for product code IRE

  • K822632 — ELBOW PROSTHESIS (September 14, 1982)