Medical Device Manufacturer · US , Midvale , UT

J-Tech, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1991

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - J-Tech, Inc. Neurology ✕

4 devices

1-4 of 4

Cleared Jul 03, 1996

SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE

Neurology · 261d

Cleared Oct 30, 1995

Neurology · 20d

Cleared May 10, 1995

LARGE MUSCLE STRENGTH GAUGE

Neurology · 175d

Cleared Sep 05, 1991

GS-220 HAND IMPAIRMENT EVALUATION SYSTEM

Neurology · 90d