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510(k) K841849

ISOSTATION SHOULDER MACHINE by Isotechnologies, Inc. — Product Code IKK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1984
Date Received
May 3, 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.

  • K933063 — ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA (January 27, 1994)
  • K912175 — ISOTECHNOLOGIES LIFTSTATION & LIFTWORKS SOFTWARE (June 7, 1991)
  • K854621 — ISOSTATION KNEE MACHINE (K-100) (March 7, 1986)
  • K844060 — ISOSTATION ANKLE/SUBTALAR MACHINE A-100 (November 23, 1984)
  • K842296 — ISOSTATION LOWER BACK MACHINE (June 22, 1984)

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  • K944732 — DEXTER ISOKINETIC (February 3, 1995)
  • K924414 — THE BTE DYNAMIC LIFT (February 12, 1993)
  • K923350 — CLOSED CHAIN ATTACHMENT, MODEL #820-520 (July 23, 1992)
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