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FDA 510(k)

GyroStim

K-Number: K220231 · 2022-04-27

ApplicantUltrathera Technologies, Inc.
Decision Date2022-04-27
Product CodeLXV
DecisionSubstantially Equivalent

Device Summary

GyroStim is the device name listed in this FDA 510(k) record. The listed applicant is Ultrathera Technologies, Inc.. It received FDA 510(k) clearance on 2022-04-27 under 510(k) number K220231. The device is classified under product code LXV. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GyroStim?

GyroStim is a medical device that received FDA 510(k) clearance on 2022-04-27. The listed applicant is Ultrathera Technologies, Inc.. The 510(k) number is K220231.

When did GyroStim receive FDA 510(k) clearance?

GyroStim received FDA 510(k) clearance on 2022-04-27, under 510(k) number K220231.

Who is the listed applicant for GyroStim?

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

What is the FDA product code for GyroStim?

The FDA product code for GyroStim is LXV.

Related Devices (Code: LXV)

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.

K200529OrionInteracoustics A/SK192652TRVInteracoustics A/SK183661ClearEdge Balance SystemQuadrant BiosciencesK190735EQ BalanceUpright Science, Inc.K173669K-D BalanceKing-Devick Technologies, 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.

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