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FDA 510(k)

HBOTC Muscle and Nerve Stimulator

K-Number: K160255 · 2016-09-15

ApplicantHb Medical, Inc.
Decision Date2016-09-15
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HBOTC Muscle and Nerve Stimulator is a medical device manufactured by Hb Medical, Inc.. It received FDA 510(k) clearance on 2016-09-15 under approval number K160255. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HBOTC Muscle and Nerve Stimulator?

HBOTC Muscle and Nerve Stimulator is a medical device that received FDA 510(k) clearance on 2016-09-15. It is manufactured by Hb Medical, Inc.. The 510(k) number is K160255.

When was HBOTC Muscle and Nerve Stimulator approved by the FDA?

HBOTC Muscle and Nerve Stimulator received FDA 510(k) clearance on 2016-09-15, under approval number K160255.

What company makes HBOTC Muscle and Nerve Stimulator?

HBOTC Muscle and Nerve Stimulator is manufactured by Hb Medical, Inc..

What is the FDA product code for HBOTC Muscle and Nerve Stimulator?

The FDA product code for HBOTC Muscle and Nerve Stimulator is NUH.

Related Clinical Trials

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Official Source

View on FDA Database →

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

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