Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ReGrasp

K-Number: K153163 · 2016-04-07

ApplicantRehabtronics, Inc.
Decision Date2016-04-07
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ReGrasp is a medical device manufactured by Rehabtronics, Inc.. It received FDA 510(k) clearance on 2016-04-07 under approval 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. It is manufactured by Rehabtronics, Inc.. The 510(k) number is K153163.

When was ReGrasp approved by the FDA?

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

What company makes ReGrasp?

ReGrasp is manufactured by Rehabtronics, Inc..

What is the FDA product code for ReGrasp?

The FDA product code for ReGrasp is GZI.

Other Devices by Rehabtronics, Inc.

K210979Prelivia

Related Devices (Code: GZI)

K162718Foot Drop System (Model XFT-2001D)Shenzhen Xft Medical Limited K170564MyndMove System, MyndMove Functional Electrical StimulatorMyndtec, Inc. K162470RT300 FES cycle ergometerRestorative Therapies, Inc. K170132MyoCycle Home, MyoCycle ProMyolyn, LLC K162683RehaStim 2Hasomed GmbH K162407L300 Go SystemBioness, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑