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510(k) K954737

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

K954737 is an FDA 510(k) premarket notification submitted by J-Tech, Inc. for the device "SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE". The FDA issued a decision of Substantially Equivalent on July 3, 1996. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. J-Tech, Inc. has at least 4 other 510(k) clearances on record.

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)

Other clearances for product code HCC

  • K233580 — A Breathing System (ABS) (August 1, 2024)
  • K222101 — Prism (March 17, 2023)
  • K180173 — Freespira (August 23, 2018)
  • K163448 — GrindCare System (September 1, 2017)
  • K151050 — Pacifier Activated Lullaby (PAL®) (December 22, 2015)
  • K143507 — NFANT Feeding Solution (September 9, 2015)
  • K131586 — CANARY BREATHING SYSTEM (December 10, 2013)
  • K122879 — EEGER4 MODEL 4.3 (February 6, 2013)
  • K111687 — EMG SYSTEM (September 29, 2011)
  • K092675 — GRINDCARE (March 3, 2010)

FDA data resources