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510(k) K881681

CYBEX BACK TESTING AND REHABILITATION SYSTEM by Cybex — Product Code IKK

K881681 is an FDA 510(k) premarket notification submitted by Cybex for the device "CYBEX BACK TESTING AND REHABILITATION SYSTEM". The FDA issued a decision of Substantially Equivalent on April 25, 1990. The device falls under product code IKK (System, Isokinetic Testing And Evaluation), a Class II device regulated under 21 CFR 890.1925. Cybex has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1990
Date Received
April 19, 1988
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 Cybex

  • K950095 — CYBEX 770 (June 21, 1995)
  • K905525 — CYBEX 6000 (February 14, 1991)
  • K881676 — LINEAR LIFT DEVICE (April 25, 1990)
  • K894154 — METABOLIC SYSTEMS (October 24, 1989)
  • K873599 — EDI 320 (October 16, 1987)
  • K872911 — CYBEX 340 (September 24, 1987)
  • K844368 — LINEAR LIFT DEVICE (February 19, 1985)
  • K843739 — CYBEX TORSO TESTING & REHABILITATION (November 29, 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