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510(k) K912526

GS-220 HAND IMPAIRMENT EVALUATION SYSTEM by J-Tech, Inc. — Product Code LBB

K912526 is an FDA 510(k) premarket notification submitted by J-Tech, Inc. for the device "GS-220 HAND IMPAIRMENT EVALUATION SYSTEM". The FDA issued a decision of Substantially Equivalent on September 5, 1991. The device falls under product code LBB (Dynamometer, Ac-Powered), a Class II device regulated under 21 CFR 888.1240. J-Tech, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1991
Date Received
June 7, 1991
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 J-Tech, Inc.

  • K954737 — SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE (July 3, 1996)
  • K954647 — INCLINOMETER (October 30, 1995)
  • K945630 — LARGE MUSCLE STRENGTH GAUGE (May 10, 1995)
  • K913587 — JTECH 50 SERIES CUTTING LOOP (October 23, 1991)

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