Home / 510(k) Clearances / K933063

510(k) K933063

ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA by Isotechnologies, Inc. — Product Code KQX

K933063 is an FDA 510(k) premarket notification submitted by Isotechnologies, Inc. for the device "ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA". The FDA issued a decision of Substantially Equivalent on January 27, 1994. The device falls under product code KQX (Goniometer, Ac-Powered), a Class I device regulated under 21 CFR 888.1500. Isotechnologies, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1994
Date Received
June 22, 1993
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 Isotechnologies, Inc.

  • 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)
  • K841849 — ISOSTATION SHOULDER MACHINE (May 14, 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