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510(k) K962377

3D-SPINE by Skill Technologies, Inc. — Product Code KQX

K962377 is an FDA 510(k) premarket notification submitted by Skill Technologies, Inc. for the device "3D-SPINE". The FDA issued a decision of Substantially Equivalent on September 3, 1996. The device falls under product code KQX (Goniometer, Ac-Powered), a Class I device regulated under 21 CFR 888.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1996
Date Received
June 20, 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

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

FDA data resources