Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021282523

FEI Number

3021282523

Entity Name

SHENZHEN RUIYI BUSINESS TECHNOLOGY CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

No. 810-C063, 8th Floor, Xiangbin International Financial Centre, No.18, West Free Trade Street,, China Special Economic Zone, Qianhai Bay, Shenzhen, Guangdong Province, 518000 China, Shenzhen Guangdong 518000, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Shenzhen Ruiyi Business Technology Co., Ltd. (Owner Number: 10083379)

Owner / Operator Contact Address

No. 810-C063, 8th Floor, Xiangbin International Financial Centre, No.18, West Free Trade Street, China Special Economic Zone, Qianhai Bay, Shenzhen, CN-GD 518000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232713

PMA Number

N/A

All Registered Proprietary Names

Memory Foam Sleeping Pillow: R-WTS01 Overlapped Compression Therapy: YY-A02-B Air Compression Therapy Device: ST-502 TEETH WHITENING PEN:RP-TWG3-4 TEETH WHITENING KIT: RP-TW16-2,RP-TW16,RP-TW32 Smart Blood Pressure Monitor,TMB-1872-B Vibration Eye Mask: R-GS001; EyeSnooze Sleep Mask: R-GS002; Sleep Mask: R-GS003; Ice Head Wrap: R-GC001 Smart scale: R-MSC01,R-A009,R-A012,R-A016, ES-BR001,ES-WBE28,FT-26BB-B Smart scale:FT-28WBL, R-A005, FT-26R-B,R-A031,R-A020 Body Fat Scale: R-A017, ES-26BB-B, R-A018, R-A033, R-MSB01, R-MSB02 Body Composition Scale: R-MSC04,R-MSB05,R-MSB04,R-MSC05,R-MSC06 Body composition scale:ES-CS20M,ES-CS20M-W,FT-24D,R-A003,ES-26R-B, R-A019,FA-01, FA-03 Body Composition Scale: R-A032, ES-24M, ES-26M,ES-28ML,ES-30M,ES-32MD,ES-BR003 Leg Massager: RP-ALM070H,RP-ALM071H Massage Pillow:RF-NM067 Wifi Smart Foot Massager:RF-FM059HS Eye Massager: RF-EM001, RF-EM001R, R-G001, R-G002, R-G009, R-G004, R-G006, PH-G01, R-G008, R-G010V, RF-EM001V, PH-G02 Foot Massager:R-D001R, R-D200R, RF-FM059, RF-FM059R, RF-FM059R-H, RF-FM062, RF-FM063, RF-FM065, RP-FM057R, RP-FM058R, Foot Massager:RP-FM069R, RP-FM079R, R-D003R, R-WMF03, R-WMF02, R-WMF04, P-WMF01 Hand Massager:R-H001 Massage gun:R-WMG82 ,R-WMG83 ,R-WMG07 ,R-C001SH ,R-WAG84 ,RP-GM171 ,RP-GM171H, R-WMG02,R-WMG03,R-WMG05,R-WMG11 2 in 1 Foot and Calf Massager:R-D002RS Massage Cushion:R-E002,P-WMB01 Hot Stone Spa Set: X-WMX08 Eye Massager: R-G002S, R-G003, R-G007, R-G011 Hot stone massager: S1; Hot stone massager: S2, S2A, S2B Head Massager:R-V002, R-V003 Smart Foot and Calf Massager:R-D001RS Massage Cushion: RF-BM076 Foot Spa Massager:JD-618,R-X001, R-X002, Red Light Waist Band: R-WTR01 Heated Knee and Calf Massager:R-F003 Massage Gun:R-C004 ,R-C003H ,RP-GM171-N1 ,R-C007 ,R-C002S ,R-C002SH ,R-C003H-N1 ,FB-03H ,R-WMG01 ,R-WMG08 ,R-WMG81 SCALP MASSAGER:R-V001 Smart Eye Massager: RF-EM001S; Head and Eye Massager: R-WME01; Eye Massager: R-WME02, R-WME04, R-WME05 Full Body Massage Mat:R-E001;Multifunctional Massage Pad:R-WMX01 Handheld Massager:RF-EM2018C, RP-EM2020W Cordless Massager:EM-2016C, RP-EM2020C Professional Massage Gun:RP-GM180 Massage gun: R-WMG06 ,FB-01 ,FB-02 ,FT-MG001 ,FT-MG002 ,R-C001 ,R-C001S ,R-C003 ,R-C005 ,RF-GM168 ,RF-GM169 ,FB-03 Shoulder & Neck Massager:RF-SNM060,RP-SNM066 ,R-WMN01;Neck And Shoulder Massager:RP-SNM061 Foot Massager: R-WMF09,R-WMF10,R-WMF07,R-WMF06 Vibrating Foam Roller:FT-YB-03 ,FT-YB-02 ,FT-YB-01 Pillow Massager:RP-NM068 ,RP-NM069 Neck Massager:R-W001 ,R-L001 Abdominal Massager:I-B-101 Mini Massage Gun:AV-003 ,AV014 ,RP-GM172 ,RP-GM173 ,R-WMG10 Eye Massager: R-WME06, R-WME07, R-WME08, R-WME09 Electric Cupping Massager: R-WMV01 Heated Blanket:I-C-026, I-C-010 Heating Pad: R-HAP64,R-HAP61,R-HAP62,R-HAP60,I-C-08, I-C-09, I-HAP06, R-HAP03, R-U005, R-U012, R -HAP67, R-HAP68 Cordless Heating Pad:I-I-01,I-I-101,I-I-102 Heating Pad:NA-H1222D,R-U006,R-U010,R-U011,I-I-03,I-I-04,I-I-105,I-I-106,R-U002,R-HAP01,R-HAP02,I-HAP03,I-HAP04,I-HAP05 Heating Pad: R-HAP65, I-HAP01, I-HAP02 Leg Massager: RF-ALM070 Air compression Leg Massager : MM0521, MM0522 Blood Pressure Monitor: TMB-2276-B

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2024-06-27
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2023-04-21
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2023-08-15
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2023-05-26
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-05-18
PHW	Cold Pack And Vibrating Massager	Physical Medicine	Class 1	890.5975	2022-03-31
PUH	Analyzer, Body Composition, Exempt	Cardiovascular	Class 2	870.2770	2022-01-28
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2025-02-12
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2022-01-28
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2021-12-02
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2023-02-02
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2025-08-04
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2025-08-04
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2025-06-25
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2025-06-25
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2022-03-30
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-04-19

Official Correspondent

Derric Bai

US Agent Details

derric bai Business: JOICOM CORPORATION Email: compliance@renpho.com Phone: (951) 7517006

Related Public Records

Same Entity

Shenzhen Ruiyi Business Technology Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K242140	Jiale Health Technology Shenzhen Co., Ltd.	Air Compression Leg Massager (K-705)	2025-03-17
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12
K152003	Andon Health Co, Ltd.	iHealth BP3L Wireless Blood Pressure Monitor	2015-09-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021282523. Last updated year: 2026. Please use registration number 3021282523 when referencing this establishment in official correspondence.