FDA-Cleared & Dual-Function Therapy FDA-cleared (K190673) Class II medical device combining TENS (Mode 9-25) for temporary pain relief and PMS (Mode 1-8) to improve muscle performance. Complies with 21 CFR 882.5890/890.5850.
Customizable Modes for Targeted Relief Features 25 preset programs and 99 intensity levels to address sore muscles in shoulders, back, neck, arms, legs, and feet—ideal for post-workout recovery or daily strain.
Safe & Clinically Validated Technology Delivers balanced biphasic pulses (max 44V@500Ω) with ISO 10993-5/10 biocompatible electrode pads. Tested for electrical safety (IEC 60601-1), EMC, and usability (IEC 62366-1).
User-Friendly Design with Full-Body Support Includes 4 body electrode pads + 2 sole pads for feet stimulation. LCD screen displays mode, intensity, and timer (25-min auto shutoff). Lightweight (1.9kg) and portable.
Substantially Equivalent to Predicate Devices Proven equivalent to AST-300C/D (K133929) with identical waveforms, pulse frequency (77.3Hz), and safety features. Global voltage compatible (100-240V).
Overview
Product Dimensions : 3.2 x 1.2 x 2.2 inches; 8.47 ounces
Item model number : B0FGXMNQ2S
Date First Available : July 7, 2025
Manufacturer : CWTUL
ASIN : B0FGXMNQ2S
Best Sellers Rank: #520,848 in Health & Household (See Top 100 in Health & Household) #1,199 in Electric Foot Massagers #129,519 in Health Care Products
