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RecoveryAir PRO

by Theragun, Inc.

510(k) K211745

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK211745 Date4 Oct 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IRP
Device Class
Class II
Regulation
21 CFR Part 890.5650
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The RecoveryAir Pro is a powered inflatable tube massager that utilizes clinical-grade compression technology to help reduce delayed onset muscle soreness, decrease swelling and stiffness, and relieve muscle fatigue. It is a pneumatic device designed to contribute to faster recovery and improved performance.

The RecoveryAir Pro system is supplied as a fully customizable pneumatic compression system with a hygienic design featuring 4 internal overlapping chambers. It is intended for use in physical medicine and is regulated under the product code IRP, with a regulation number of 890.5650. The device has been authorized with an FDA 510K clearance.

Other devices from Theragun, Inc.

Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the RecoveryAir PRO used for?

    The RecoveryAir PRO is used to help reduce delayed onset muscle soreness, decrease swelling and stiffness, and relieve muscle fatigue, contributing to faster recovery and improved performance.

  • Is the RecoveryAir PRO a single-use device?

    The description does not specify if the RecoveryAir PRO is for single-use or reuse, but it features a hygienic design, suggesting it may be reusable with proper cleaning and maintenance.

  • What kind of technology does the RecoveryAir PRO utilize?

    The RecoveryAir PRO utilizes clinical-grade compression technology through a pneumatic system with 4 internal overlapping chambers to provide customizable compression.

  • What regulatory clearance has the RecoveryAir PRO received?

    The RecoveryAir PRO has received FDA 510K clearance, indicating it is substantially equivalent to a predicate device.