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FDA 510(k)

AMIGO CATEGORY III FULL-SIZED REGULAR DUTY 3 WHEEL (310000) AND AMIGO CATEGORY V HEAVY DUTY 3 WHEEL (650000)

K-Number: K090966 · 2009-05-15

ApplicantSvrc Industries, Inc.
Decision Date2009-05-15
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AMIGO CATEGORY III FULL-SIZED REGULAR DUTY 3 WHEEL (310000) AND AMIGO CATEGORY V HEAVY DUTY 3 WHEEL (650000) is the device name listed in this FDA 510(k) record. The listed applicant is Svrc Industries, Inc.. It received FDA 510(k) clearance on 2009-05-15 under 510(k) number K090966. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMIGO CATEGORY III FULL-SIZED REGULAR DUTY 3 WHEEL (310000) AND AMIGO CATEGORY V HEAVY DUTY 3 WHEEL (650000)?

AMIGO CATEGORY III FULL-SIZED REGULAR DUTY 3 WHEEL (310000) AND AMIGO CATEGORY V HEAVY DUTY 3 WHEEL (650000) is a medical device that received FDA 510(k) clearance on 2009-05-15. The listed applicant is Svrc Industries, Inc.. The 510(k) number is K090966.

When did AMIGO CATEGORY III FULL-SIZED REGULAR DUTY 3 WHEEL (310000) AND AMIGO CATEGORY V HEAVY DUTY 3 WHEEL (650000) receive FDA 510(k) clearance?

AMIGO CATEGORY III FULL-SIZED REGULAR DUTY 3 WHEEL (310000) AND AMIGO CATEGORY V HEAVY DUTY 3 WHEEL (650000) received FDA 510(k) clearance on 2009-05-15, under 510(k) number K090966.

Who is the listed applicant for AMIGO CATEGORY III FULL-SIZED REGULAR DUTY 3 WHEEL (310000) AND AMIGO CATEGORY V HEAVY DUTY 3 WHEEL (650000)?

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

What is the FDA product code for AMIGO CATEGORY III FULL-SIZED REGULAR DUTY 3 WHEEL (310000) AND AMIGO CATEGORY V HEAVY DUTY 3 WHEEL (650000)?

The FDA product code for AMIGO CATEGORY III FULL-SIZED REGULAR DUTY 3 WHEEL (310000) AND AMIGO CATEGORY V HEAVY DUTY 3 WHEEL (650000) is INI.

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Related Devices (Code: INI)

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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