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FDA 510(k)

REHASTIM 2, REHAMOVE 2

K-Number: K112844 · 2011-10-27

ApplicantHasomed GmbH
Decision Date2011-10-27
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

REHASTIM 2, REHAMOVE 2 is the device name listed in this FDA 510(k) record. The listed applicant is Hasomed GmbH. It received FDA 510(k) clearance on 2011-10-27 under 510(k) number K112844. 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 REHASTIM 2, REHAMOVE 2?

REHASTIM 2, REHAMOVE 2 is a medical device that received FDA 510(k) clearance on 2011-10-27. The listed applicant is Hasomed GmbH. The 510(k) number is K112844.

When did REHASTIM 2, REHAMOVE 2 receive FDA 510(k) clearance?

REHASTIM 2, REHAMOVE 2 received FDA 510(k) clearance on 2011-10-27, under 510(k) number K112844.

Who is the listed applicant for REHASTIM 2, REHAMOVE 2?

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

What is the FDA product code for REHASTIM 2, REHAMOVE 2?

The FDA product code for REHASTIM 2, REHAMOVE 2 is GZI.

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Other records listing Hasomed GmbH 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.

K162683RehaStim 2K073237REHASTIM & REHAMOVE

Related Devices (Code: GZI)

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

View on FDA Database →

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

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