FDA 510(k)

TheraFace LED

K号: K212155 · 2021-12-21

决定日期2021-12-21

产品代码OHS

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决定实质等同

器械摘要

TheraFace LED is the device name listed in this FDA 510(k) record. The listed applicant is Theragun, Inc.. It received FDA 510(k) clearance on 2021-12-21 under 510(k) number K212155. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TheraFace LED?

TheraFace LED is a medical device that received FDA 510(k) clearance on 2021-12-21. The listed applicant is Theragun, Inc.. The 510(k) number is K212155.

When did TheraFace LED receive FDA 510(k) clearance?

TheraFace LED received FDA 510(k) clearance on 2021-12-21, under 510(k) number K212155.

Who is the listed applicant for TheraFace LED?

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

What is the FDA product code for TheraFace LED?

The FDA product code for TheraFace LED is OHS.

列明Theragun, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K211745RecoveryAir PRO K212238TheraFace微电流

相关器械（代码：OHS）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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官方来源

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