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Therabody

Therabody, Inc. · Model JetBoots PRO Plus Regular · UDI-DI 00840295405575

IRP ILY IRO

510(k) clearances

Adverse events (1 deaths)

Recalls

101

Facilities

Description

RecoveryAir JetBoots Pro is a pair of pneumatic compression boots that incorporate vibration and IR technologies. These new features will enhance recovery of legs throughout their combination in different preset programs. The device is designed to work in pairs with a master boot, with a main control panel, and a dummy boot. Additionally, it will be Bluetooth enabled to connect with the Therabody App where user can access to more settings, presets, and track overall usage

Recalls

Date	Firm	Reason
2025-01-17	Zhejiang Luyao Electronics Technology Co., Ltd.	Regulatory documentation error and misleading color packaging claim.
2023-03-07	Compass Health Brands (Corporate Office)	Error in the Introduction section of the user manual that indicates the device may be used for the prevention of deep vein thrombosis (DVT). Marketed without a 510k for this indica
2017-01-13	Won Industry Co.	Distribution of unapproved devices with incorrect air compression level setup
2017-01-13	Won Industry Co.	Distribution of unapproved devices with incorrect air compression level setup
2011-08-23	CoolSystems, Inc.	It was discovered that some Game Ready Professional Therapy System units that were to have been quarantined pending final inspection and testing were inadvertently moved to finishe

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.