ROOVJOY TENS/EMS Devices Specification Produced by Shenzhen Roundwhale Technology Co., Ltd.

2 Channel 3 IN 1 (TENS+EMS+MASSAGE) 4 50*50mm pads (Japan gel) Product Features: 4 AAA alkaline batteries 6 Body parts 36 Programs 60 Levels 60 mA (at 1000 Ohm load) 2 Channel 4 IN 1 (TENS+EMS+RUSS+IF) 4 50*50mm pads (Japan gel) Treating area: TENS: shoulder, back, arm, leg, hip and joint EMS: shoulder, arm, back, leg and hip Treating program: TENS: 18 programs EMS: 15 programs MASSAGE: 3 massage manipulations Optional Adjustable Program 10 Body parts 93 Programs(TENS 18 + MASS 3) 90 Levels 90 mA (at 1000 Ohm load) LCD Type: VA/HTN Backlight: white 800 mA Rechargeable Li-ion battery

Product Features: 2 Channel 3 IN 1 (TENS+EMS+MASS) 4 50*50mm pads (Japan gel) 22 Programs 40 Levels 120 Max. 120mA (at 500 Ohm load) 500 mA Rechargeable Li-ion battery S Treating channel: 2 S Treating strength:Max.120mA (500 Ohm load) S Treating intensity: 0-40levels,adjustable S Treating frequency: 2Hz-100Hz S Treating pulse width: 100uS-300uS S Treating time: 30mins S LCD Type: HTN S Backlight: white S Color: Purple or blue(optional) S Treating Mode: TENS/EMS/MASSAGE S Treating area: • TENS: shoulder, back, arm, leg, hip and joint • EMS: shoulder, arm, back, leg and hip S Treating program:...

R-C4A (Small, fashionable) Product Features: 2 Channel 3 IN 1 (TENS+EMS+MASS) Treating Mode： TENS/EMS/MASSAGE Treating program: TENS: 30 programs , adjustable 10 programs EMS: 27 programs , adjustable 9 programs MASSAGE: 3 massage manipulations Optional Adjustable Program(Hz/Us/Time) Treating channel: 2 Treating strength:Max.120mA (500 Ohm load) Treating intensity: 0-40levels,adjustable Treating frequency: 2Hz-120Hz Treating pulse width: 100uS-300uS Treating time: 5-90mins 4 50*50mm pads (Japan gel) 10 Body parts 40 Levels 60 Programs 120 Max.120mA (at 500 Ohm load) 500 mA Rechargeable Li-ion...

R-C4B(Small, fashionable) Product Features: 2 Channel 3 IN 1 (TENS+EMS+MASS) Treating Mode： TENS/EMS/MASSAGE Treating program: TENS: 10 programs EMS: 9 programs MASSAGE: 3 massage manipulations Optional Adjustable Program(Hz/Us/Time) Treating channel: 2 Treating strength:Max.120mA (500 Ohm load) Treating intensity: 0-40levels,adjustable Treating frequency: 2Hz-120Hz Treating pulse width: 100uS-300uS Treating time: 5-90mins 3 AAA alkaline batteries 4 50*50mm pads (Japan gel) 10 Body parts 22 Programs 40 Levels 120 Max.120mA (at 500 Ohm load) LCD Type : HTN Backlight: white Body parts : TENS: NECK,...

R-C4D (Best Buy) Product Features: 2 Channel 3 AAA alkaline batteries 4 50*50mm pads (Japan gel) Treating Mode： TENS Treating program: TENS: 12 programs, adjustable 3 programs Optional Adjustable Program(Hz/Us/Time) Treating channel: 2 Treating strength:Max.120mA (500 Ohm load) Treating intensity: 0-40levels,adjustable Treating frequency: 2Hz-120Hz Treating pulse width: 100uS-300uS Treating time: 5-90mins 12 Programs 40 Levels 120 Max.120mA (at 500 Ohm load)

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Production workshop

U.S. FOOD & DRUG ADMINISTRATION Shenzhen Roundwhale Technology Co., Ltd. Kevin Zhang General Manager No. 615, Building C of Sanlian Industrial Zone, Shiyan Baoan District Shenzhen, GuangDong, 518108 Cn Re: K181688 Trade/Device Name: R-Cl TENS and EMS Stimulator; R-E'I EMS Stimulator; R-Tl TENS Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ Dated: June 6, 2018 Received: June 26, 2018 Dear Kevin Zhang: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above...

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