Home / 510(k) Clearances / K961212

510(k) K961212

SPINAL TOUCH by Fasstech — Product Code KQX

K961212 is an FDA 510(k) premarket notification submitted by Fasstech for the device "SPINAL TOUCH". The FDA issued a decision of Substantially Equivalent on June 12, 1996. The device falls under product code KQX (Goniometer, Ac-Powered), a Class I device regulated under 21 CFR 888.1500. Fasstech has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1996
Date Received
March 28, 1996
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 Fasstech

  • K063447 — INSIGHT DISCOVERY (August 16, 2007)
  • K033452 — CWAS 1000 (November 28, 2003)
  • K023209 — INSIGHT MILLENNIUM III (October 10, 2003)
  • K011964 — INSIGHT MILLENNIUM PLUS (September 20, 2001)
  • K011983 — INSIGHT GENESIS (August 30, 2001)
  • K990778 — INSIGHT MILLENNIUM (June 3, 1999)
  • K940050 — FOCUS EMG (February 24, 1995)
  • K925197 — PSI 220 DUAL EMG (February 2, 1993)

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)
  • 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)
  • K933063 — ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA (January 27, 1994)

FDA data resources