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510(k) K844060

ISOSTATION ANKLE/SUBTALAR MACHINE A-100 by Isotechnologies, Inc. — Product Code IKK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1984
Date Received
October 18, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Isokinetic Testing And Evaluation
Device Class
Class II
Regulation Number
890.1925
Review Panel
PM
Submission Type

Other clearances by Isotechnologies, Inc.

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  • K854621 — ISOSTATION KNEE MACHINE (K-100) (March 7, 1986)
  • K842296 — ISOSTATION LOWER BACK MACHINE (June 22, 1984)
  • K841849 — ISOSTATION SHOULDER MACHINE (May 14, 1984)

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