SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE— 510(k) K954737

Name: FDA 510(k) clearance K954737
Creator: U.S. Food and Drug Administration
Published: 1996-07-03

Substantially Equivalent

J-Tech, Inc.

FDA 510(k) clearance K954737 for SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE, Substantially Equivalent on 1996-07-03. Applicant: J-Tech, Inc.. Device class: 2.

Clearance details

Applicant: J-Tech, Inc.
Product code: Code HCC
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 1995-10-16
Decision date: 1996-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpine, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HCC

view all

K233580 — A Breathing System (ABS)2024-08-01
K222101 — Prism2023-03-17
K180173 — Freespira2018-08-23
K163448 — GrindCare System2017-09-01
K151050 — Pacifier Activated Lullaby (PAL®)2015-12-22

More clearances from J-Tech, Inc.

view all

K954647 — INCLINOMETER1995-10-30
K945630 — LARGE MUSCLE STRENGTH GAUGE1995-05-10
K913587 — JTECH 50 SERIES CUTTING LOOP1991-10-23
K912526 — GS-220 HAND IMPAIRMENT EVALUATION SYSTEM1991-09-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.