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FDA 510(k)

TimeWaver Frequency

K-Number: K212832 · 2021-12-14

ApplicantTimewaver Production GmbH
Decision Date2021-12-14
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TimeWaver Frequency is the device name listed in this FDA 510(k) record. The listed applicant is Timewaver Production GmbH. It received FDA 510(k) clearance on 2021-12-14 under 510(k) number K212832. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TimeWaver Frequency?

TimeWaver Frequency is a medical device that received FDA 510(k) clearance on 2021-12-14. The listed applicant is Timewaver Production GmbH. The 510(k) number is K212832.

When did TimeWaver Frequency receive FDA 510(k) clearance?

TimeWaver Frequency received FDA 510(k) clearance on 2021-12-14, under 510(k) number K212832.

Who is the listed applicant for TimeWaver Frequency?

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

What is the FDA product code for TimeWaver Frequency?

The FDA product code for TimeWaver Frequency is IPF.

Other records listing Timewaver Production 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.

K191075Healy

Related Devices (Code: IPF)

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

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

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