FDA 510(k)

ReGrasp

K-Number: K153163 · 2016-04-07

Decision Date2016-04-07

Product CodeGZI

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ReGrasp is the device name listed in this FDA 510(k) record. The listed applicant is Rehabtronics, Inc.. It received FDA 510(k) clearance on 2016-04-07 under 510(k) number K153163. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ReGrasp?

ReGrasp is a medical device that received FDA 510(k) clearance on 2016-04-07. The listed applicant is Rehabtronics, Inc.. The 510(k) number is K153163.

When did ReGrasp receive FDA 510(k) clearance?

ReGrasp received FDA 510(k) clearance on 2016-04-07, under 510(k) number K153163.

Who is the listed applicant for ReGrasp?

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

What is the FDA product code for ReGrasp?

The FDA product code for ReGrasp is GZI.

Other records listing Rehabtronics, Inc. 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.

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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.