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510(k) K954737

SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE by J-Tech, Inc. — Product Code HCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1996
Date Received
October 16, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biofeedback
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type

Other clearances by J-Tech, Inc.

  • K954647 — INCLINOMETER (October 30, 1995)
  • K945630 — LARGE MUSCLE STRENGTH GAUGE (May 10, 1995)
  • K913587 — JTECH 50 SERIES CUTTING LOOP (October 23, 1991)
  • K912526 — GS-220 HAND IMPAIRMENT EVALUATION SYSTEM (September 5, 1991)

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