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FDA 510(k)

RUMBLE TUFF

K-Number: K113315 · 2012-11-20

ApplicantAcute Ideas Co. , Ltd.
Decision Date2012-11-20
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

RUMBLE TUFF is the device name listed in this FDA 510(k) record. The listed applicant is Acute Ideas Co. , Ltd.. It received FDA 510(k) clearance on 2012-11-20 under 510(k) number K113315. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUMBLE TUFF?

RUMBLE TUFF is a medical device that received FDA 510(k) clearance on 2012-11-20. The listed applicant is Acute Ideas Co. , Ltd.. The 510(k) number is K113315.

When did RUMBLE TUFF receive FDA 510(k) clearance?

RUMBLE TUFF received FDA 510(k) clearance on 2012-11-20, under 510(k) number K113315.

Who is the listed applicant for RUMBLE TUFF?

The FDA 510(k) record lists Acute Ideas Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RUMBLE TUFF?

The FDA product code for RUMBLE TUFF is HGX.

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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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Other records listing Acute Ideas Co. , Ltd. 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.

K023711DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE

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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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