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FDA 510(k)

RecoveryAir PRO

K-Number: K211745 · 2021-10-04

Decision Date2021-10-04
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

RecoveryAir PRO is the device name listed in this FDA 510(k) record. The listed applicant is Theragun, Inc.. It received FDA 510(k) clearance on 2021-10-04 under 510(k) number K211745. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RecoveryAir PRO?

RecoveryAir PRO is a medical device that received FDA 510(k) clearance on 2021-10-04. The listed applicant is Theragun, Inc.. The 510(k) number is K211745.

When did RecoveryAir PRO receive FDA 510(k) clearance?

RecoveryAir PRO received FDA 510(k) clearance on 2021-10-04, under 510(k) number K211745.

Who is the listed applicant for RecoveryAir PRO?

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 RecoveryAir PRO?

The FDA product code for RecoveryAir PRO is IRP.

Other records listing Theragun, Inc. 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.

Related Devices (Code: IRP)

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.

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.