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FDA 510(k)

AMES THERAPY DEVICE

K-Number: K123746 · 2013-05-24

ApplicantAmes Technology, Inc.
Decision Date2013-05-24
Product CodeIKK
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AMES THERAPY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Ames Technology, Inc.. It received FDA 510(k) clearance on 2013-05-24 under 510(k) number K123746. The device is classified under product code IKK. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMES THERAPY DEVICE?

AMES THERAPY DEVICE is a medical device that received FDA 510(k) clearance on 2013-05-24. The listed applicant is Ames Technology, Inc.. The 510(k) number is K123746.

When did AMES THERAPY DEVICE receive FDA 510(k) clearance?

AMES THERAPY DEVICE received FDA 510(k) clearance on 2013-05-24, under 510(k) number K123746.

Who is the listed applicant for AMES THERAPY DEVICE?

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

What is the FDA product code for AMES THERAPY DEVICE?

The FDA product code for AMES THERAPY DEVICE is IKK.

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Related Devices (Code: IKK)

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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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