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510(k) K844060

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

K844060 is an FDA 510(k) premarket notification submitted by Isotechnologies, Inc. for the device "ISOSTATION ANKLE/SUBTALAR MACHINE A-100". The FDA issued a decision of Substantially Equivalent on November 23, 1984. The device falls under product code IKK (System, Isokinetic Testing And Evaluation), a Class II device regulated under 21 CFR 890.1925. Isotechnologies, Inc. has at least 5 other 510(k) clearances on record.

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.

  • 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)
  • K842296 — ISOSTATION LOWER BACK MACHINE (June 22, 1984)
  • K841849 — ISOSTATION SHOULDER MACHINE (May 14, 1984)

Other clearances for product code IKK

  • K123746 — AMES THERAPY DEVICE (May 24, 2013)
  • K952090 — HUMAC SYSTEM (December 11, 1995)
  • K951770 — BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP (November 16, 1995)
  • K951916 — CC RIDER, MODEL ME180 (October 4, 1995)
  • K950095 — CYBEX 770 (June 21, 1995)
  • K942229 — MOTIVATOR FTR 2000 (February 27, 1995)
  • K944732 — DEXTER ISOKINETIC (February 3, 1995)
  • K924414 — THE BTE DYNAMIC LIFT (February 12, 1993)
  • K923350 — CLOSED CHAIN ATTACHMENT, MODEL #820-520 (July 23, 1992)
  • K922772 — TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR (July 13, 1992)

FDA data resources