Certifications & Qualifications We Possess

US FDA Medical-Grade Clearance

Official Regulatory Clearance: Fully reviewed and
cleared by the United States Food and Drug
Administration (FDA) for commercial distribution, under
official submission number K211850.

Class II Medical Designation: Categorized strictly as a
Class II Powered Inflatable Tube Massager
(Regulation No. 21 CFR 890.5650), separating it from
generic, uncertified wellness novelties.

Clinically Verified Benefits: Engineered to provide
precision compression cycles proven to effectively
stimulate lower-limb blood circulation, reduce deep
muscle tension, and alleviate minor edema.

North American UL 1431 Appliance Safety Standard

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Rigorous Stress Testing: Independently tested and
certified under the latest North American safety
standard for Personal Hygiene and Health Care
Appliances (UL 1431-2025), Report No. M26011223SJ-

R415.

Flame-Retardant & Anti-Leakage: Validated for high-
voltage isolation, overcurrent spikes, and structural
thermal limits. Built using V-0 premium flame-retardant
composites to prevent current leaks or overheating.

Smart Power Adapter Protection: Features an
intelligent voltage-regulating adapter that safely checks
incoming currents, guaranteeing absolute reliability for
the elderly or extended multi-session use.

US FCC Electromagnetic Compatibility

Zero Cross-Signal Interference: Thoroughly certified
against Federal Communications Commission CFR47
FCC Part 15 Subpart B
parameters, under Reference
No. LCSE05135012E.

Clean Circuit Engineering: Tested within specialized
anechoic chambers to confirm that radio frequency
emissions remain far below federal limits. It will not
disrupt your Wi-Fi, smart TVs, or Bluetooth accessories.

Low Radiation Profile: Ultra-low electromagnetic
radiation emission ensures an eco-friendly, zero-
interference environment for whole-family relaxation in
living rooms or bedrooms.

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EU RoHS Hypoallergenic & Eco-Friendly Guard

100% Skin-Safe Materials: Heavily audited against EU
RoHS Directive 2011/65/EU and its amendment
Directive (EU) 2015/863, Certificate No.
No.CTB25111010603.

Zero Harmful Heavy Metals: Verified via full chemical
degradation mapping to contain absolutely no lead,
mercury, cadmium, hexavalent chromium, or toxic
plasticizers (DEHP, BBP, DBP, DIBP).

Ideal for Seniors & Sensitive Skin: Constructed using
top-tier breathable fabrics that remain neutral and odor-
free even under intense heat cycles, defending
sensitive skin from chemical breakouts.