Identifiers
- 510(k) Number
- K241256 FDA 510(k)
- FDA Product Code
- IRP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5650 FDA 510(k)
- Regulation Number
- 890.5650 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The JetBoots PRO Plus is a powered inflatable tube massager designed for physical medicine use. It combines pneumatic compression, vibration, and infrared LED light therapy to support recovery of the legs. The device is indicated to help reduce muscle soreness, decrease swelling, and alleviate fatigue following physical exertion. It is classified as a Class II medical device under product code IRP and is regulated under regulation number 890.5650.
The JetBoots PRO Plus is supplied as a wireless, single-use or reusable system depending on user handling and maintenance, though the data does not specify sterility or reprocessing instructions. It is intended for use in clinical or athletic settings by trained users or under professional guidance. The device is not described as MRI-safe in the provided data, and no storage conditions are specified. It was authorized through the FDA 510(k) process under K241256 with a substantial equivalence decision.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: JetBoots PRO Plus | Compression + LED - Therabody, JetBoots PRO Plus Refurbished - therabody.com, THERABODY JETBOOTS PRO PLUS USER MANUAL Pdf Download, Therabody JetBoots Pro Plus Review: Are They Worth Buying?
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241256 | Class II | Active |
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Manufacturer
- Manufacturer
- Therabody, Inc.
Sources (1)
- FDA 510(k) K241256 24 fields · synced Sep 28, 2026