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FDA 510(k)

CP Relief Wand-OTC

K-Number: K162630 · 2016-12-20

ApplicantMid-America Medical Innovations, LLC
Decision Date2016-12-20
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CP Relief Wand-OTC is the device name listed in this FDA 510(k) record. The listed applicant is Mid-America Medical Innovations, LLC. It received FDA 510(k) clearance on 2016-12-20 under 510(k) number K162630. 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 CP Relief Wand-OTC?

CP Relief Wand-OTC is a medical device that received FDA 510(k) clearance on 2016-12-20. The listed applicant is Mid-America Medical Innovations, LLC. The 510(k) number is K162630.

When did CP Relief Wand-OTC receive FDA 510(k) clearance?

CP Relief Wand-OTC received FDA 510(k) clearance on 2016-12-20, under 510(k) number K162630.

Who is the listed applicant for CP Relief Wand-OTC?

The FDA 510(k) record lists Mid-America Medical Innovations, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CP Relief Wand-OTC?

The FDA product code for CP Relief Wand-OTC is NUH.

Related Devices (Code: NUH)

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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