FDA 510(k)

Dual output digital therapy massager

K-Number: K172834 · 2018-09-06

ApplicantShenzhen Osto Technology Co., Ltd.

Decision Date2018-09-06

Product CodeNUH

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Dual output digital therapy massager is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Osto Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-09-06 under 510(k) number K172834. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dual output digital therapy massager?

Dual output digital therapy massager is a medical device that received FDA 510(k) clearance on 2018-09-06. The listed applicant is Shenzhen Osto Technology Co., Ltd.. The 510(k) number is K172834.

When did Dual output digital therapy massager receive FDA 510(k) clearance?

Dual output digital therapy massager received FDA 510(k) clearance on 2018-09-06, under 510(k) number K172834.

Who is the listed applicant for Dual output digital therapy massager?

The FDA 510(k) record lists Shenzhen Osto Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dual output digital therapy massager?

The FDA product code for Dual output digital therapy massager is NUH.

Other records listing Shenzhen Osto Technology Co., Ltd. as applicant

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Related Devices (Code: NUH)

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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.