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FDA 510(k)

EMG TRAINER

K-Number: K935853 · 1995-01-18

ApplicantUnitech
Decision Date1995-01-18
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EMG TRAINER is the device name listed in this FDA 510(k) record. The listed applicant is Unitech. It received FDA 510(k) clearance on 1995-01-18 under 510(k) number K935853. 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 EMG TRAINER?

EMG TRAINER is a medical device that received FDA 510(k) clearance on 1995-01-18. The listed applicant is Unitech. The 510(k) number is K935853.

When did EMG TRAINER receive FDA 510(k) clearance?

EMG TRAINER received FDA 510(k) clearance on 1995-01-18, under 510(k) number K935853.

Who is the listed applicant for EMG TRAINER?

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

What is the FDA product code for EMG TRAINER?

The FDA product code for EMG TRAINER is HCC.

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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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