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FDA 510(k)

REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM

K-Number: K111636 · 2012-04-03

ApplicantGunnell, Inc.
Decision Date2012-04-03
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM is the device name listed in this FDA 510(k) record. The listed applicant is Gunnell, Inc.. It received FDA 510(k) clearance on 2012-04-03 under 510(k) number K111636. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM?

REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM is a medical device that received FDA 510(k) clearance on 2012-04-03. The listed applicant is Gunnell, Inc.. The 510(k) number is K111636.

When did REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM receive FDA 510(k) clearance?

REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM received FDA 510(k) clearance on 2012-04-03, under 510(k) number K111636.

Who is the listed applicant for REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM?

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

What is the FDA product code for REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM?

The FDA product code for REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM is IOR.

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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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