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510(k) K893537

GREENLEAF HAND IMPAIRMENT EVALUATION SYSTEM by Greenleaf Medical Systems, Inc. — Product Code LBB

K893537 is an FDA 510(k) premarket notification submitted by Greenleaf Medical Systems, Inc. for the device "GREENLEAF HAND IMPAIRMENT EVALUATION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 10, 1989. The device falls under product code LBB (Dynamometer, Ac-Powered), a Class II device regulated under 21 CFR 888.1240. Greenleaf Medical Systems, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1989
Date Received
May 8, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dynamometer, Ac-Powered
Device Class
Class II
Regulation Number
888.1240
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)
  • K884723 — (DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM (February 8, 1989)

Other clearances for product code LBB

  • K162412 — Hoggan Scientific® microFET2™ (March 9, 2017)
  • K073154 — FACTS HAND AND PINCH GRIP COMBO (February 14, 2008)
  • K052309 — DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006 (September 27, 2005)
  • K042889 — DYNAMOMETER - MODEL FCE AND MODEL MSC (November 16, 2004)
  • K012492 — KADANCE 2000 (November 2, 2001)
  • K981730 — DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002 (July 17, 1998)
  • K980363 — ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI) (April 16, 1998)
  • K964933 — MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG) (February 3, 1997)
  • K964685 — DYNAMOMETER (January 27, 1997)
  • K935757 — GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM (April 15, 1994)

FDA data resources