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510(k) K945630

LARGE MUSCLE STRENGTH GAUGE by J-Tech, Inc. — Product Code KQX

K945630 is an FDA 510(k) premarket notification submitted by J-Tech, Inc. for the device "LARGE MUSCLE STRENGTH GAUGE". The FDA issued a decision of Substantially Equivalent on May 10, 1995. The device falls under product code KQX (Goniometer, Ac-Powered), a Class I device regulated under 21 CFR 888.1500. J-Tech, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1995
Date Received
November 16, 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 J-Tech, Inc.

  • K954737 — SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE (July 3, 1996)
  • K954647 — INCLINOMETER (October 30, 1995)
  • K913587 — JTECH 50 SERIES CUTTING LOOP (October 23, 1991)
  • K912526 — GS-220 HAND IMPAIRMENT EVALUATION SYSTEM (September 5, 1991)

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)
  • 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