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FDA 510(k)

MYOTRACE 10 BIOFEEDBACK DEVICE

K-Number: K895633 · 1990-04-13

ApplicantNoraxon USA, Inc.
Decision Date1990-04-13
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MYOTRACE 10 BIOFEEDBACK DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Noraxon USA, Inc.. It received FDA 510(k) clearance on 1990-04-13 under 510(k) number K895633. 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 MYOTRACE 10 BIOFEEDBACK DEVICE?

MYOTRACE 10 BIOFEEDBACK DEVICE is a medical device that received FDA 510(k) clearance on 1990-04-13. The listed applicant is Noraxon USA, Inc.. The 510(k) number is K895633.

When did MYOTRACE 10 BIOFEEDBACK DEVICE receive FDA 510(k) clearance?

MYOTRACE 10 BIOFEEDBACK DEVICE received FDA 510(k) clearance on 1990-04-13, under 510(k) number K895633.

Who is the listed applicant for MYOTRACE 10 BIOFEEDBACK DEVICE?

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

What is the FDA product code for MYOTRACE 10 BIOFEEDBACK DEVICE?

The FDA product code for MYOTRACE 10 BIOFEEDBACK DEVICE is HCC.

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Other records listing Noraxon USA, 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.

K895635MYOSYSTEM 1000 ELECTROMYOGRAPH

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.

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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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