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510(k) K841849

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

K841849 is an FDA 510(k) premarket notification submitted by Isotechnologies, Inc. for the device "ISOSTATION SHOULDER MACHINE". The FDA issued a decision of Substantially Equivalent on May 14, 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
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)

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