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FDA 510(k)

SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE

K-Number: K954737 · 1996-07-03

ApplicantJ-Tech, Inc.
Decision Date1996-07-03
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is J-Tech, Inc.. It received FDA 510(k) clearance on 1996-07-03 under 510(k) number K954737. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE?

SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE is a medical device that received FDA 510(k) clearance on 1996-07-03. The listed applicant is J-Tech, Inc.. The 510(k) number is K954737.

When did SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE receive FDA 510(k) clearance?

SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE received FDA 510(k) clearance on 1996-07-03, under 510(k) number K954737.

Who is the listed applicant for SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE?

The FDA 510(k) record lists J-Tech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE?

The FDA product code for SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE is HCC.

Related Clinical Trials

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Other records listing J-Tech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K954647INCLINOMETERK945630LARGE MUSCLE STRENGTH GAUGEK913587JTECH 50 SERIES CUTTING LOOPK912526GS-220 HAND IMPAIRMENT EVALUATION SYSTEM

Related Devices (Code: HCC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233580A Breathing System (ABS)Deepwell Dtx, Inc.K222101PrismGraymatters Health , Ltd.K180173FreespiraPalo Alto Health Sciences, Inc.K163448GrindCare SystemSunstar Suisse S.A.K131586CANARY BREATHING SYSTEMPalo Alto Health Sciences, Inc.K122879EEGER4 MODEL 4.3Eeg Software, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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