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510(k) K884723

(DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM by Greenleaf Medical Systems, Inc. — Product Code KQX

K884723 is an FDA 510(k) premarket notification submitted by Greenleaf Medical Systems, Inc. for the device "(DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM". The FDA issued a decision of Substantially Equivalent on February 8, 1989. 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
February 8, 1989
Date Received
November 10, 1988
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.

  • K943929 — DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS) (May 15, 1995)
  • K935757 — GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM (April 15, 1994)
  • K893537 — GREENLEAF HAND IMPAIRMENT EVALUATION SYSTEM (October 10, 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)
  • 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