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510(k) K943929

DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS) by Greenleaf Medical Systems, Inc. — Product Code KQX

K943929 is an FDA 510(k) premarket notification submitted by Greenleaf Medical Systems, Inc. for the device "DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS)". The FDA issued a decision of Substantially Equivalent on May 15, 1995. The device falls under product code KQX (Goniometer, Ac-Powered), a Class I device regulated under 21 CFR 888.1500. Greenleaf Medical Systems, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1995
Date Received
August 12, 1994
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 Greenleaf Medical Systems, Inc.

  • K935757 — GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM (April 15, 1994)
  • K893537 — GREENLEAF HAND IMPAIRMENT EVALUATION SYSTEM (October 10, 1989)
  • K884723 — (DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM (February 8, 1989)

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)
  • 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