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510(k) K873599

EDI 320 by Cybex — Product Code KQX

K873599 is an FDA 510(k) premarket notification submitted by Cybex for the device "EDI 320". The FDA issued a decision of Substantially Equivalent on October 16, 1987. The device falls under product code KQX (Goniometer, Ac-Powered), a Class I device regulated under 21 CFR 888.1500. Cybex has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1987
Date Received
September 4, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Goniometer, Ac-Powered
Device Class
Class I
Regulation Number
888.1500
Review Panel
NE
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)
  • K881681 — CYBEX BACK TESTING AND REHABILITATION SYSTEM (April 25, 1990)
  • K894154 — METABOLIC SYSTEMS (October 24, 1989)
  • 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 KQX

  • K011827 — ORTELIUS 800 (August 28, 2001)
  • K971079 — INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE (July 9, 1997)
  • K962377 — 3D-SPINE (September 3, 1996)
  • K961212 — SPINAL TOUCH (June 12, 1996)
  • K954647 — INCLINOMETER (October 30, 1995)
  • K943929 — DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS) (May 15, 1995)
  • K945630 — LARGE MUSCLE STRENGTH GAUGE (May 10, 1995)
  • K943898 — SAUNDERS ELECTRONIC INCLINOMETER (November 28, 1994)
  • K940812 — INSIGHT ELECTRONIC ALIGNMENT INDICATOR (November 21, 1994)
  • K925225 — THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK (June 27, 1994)

FDA data resources