Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013733364

FEI Number

3013733364

Entity Name

Xiamen Simo Electronic Co., Ltd

City/State/Country

Xiamen Fujian, CN

Establishment Address

Floor 2 -3 1st Building No.17 North Tongsheng 2nd Rd, Tongan District, Xiamen Fujian 361100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Xiamen Simo Electronic Co., Ltd (Owner Number: 10055384)

Owner / Operator Contact Address

Floor 2 -3 1st Building No.17 North Tongsheng 2nd Rd, Tongan District, Xiamen, CN-FJ 361100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212935

PMA Number

N/A

All Registered Proprietary Names

Massage Mattress+SM-610;Massage Mattress+SM-602 Massage Roller+SM-409;NECK THERAPY PRO+1001100082;Agility Mini Vibrating ball+SM-412DB; Massage Mattress+SM-608;Massage Mattress+SM-620;Hand and wrist air press massager+SM-902 Sharper Image, 1020734, Power Boost Duo Total Body Massager+SM-810;Vibration Ball+SM-816; Pebble Gua Sha tool+SM-461;Vibration Exercise Plate+SM-910;Kneading Foot Massager+SM-506 ELECTRO STIMULATION HEATED NECK PAIN RELIEVER+SM-J60;Electric Shower Brush+SM-416 AIR COMPRESSION BOOTS+SM-526;Leg Air Compressor+SM-527 WBHLDM Portable Air Compression Ankle and Foot Massager with Heat Care Recovery Care Relax: SM-519/SM-523 Massage Roller: SM-409 Ezwell Remedy Massage System: SM-610 Vibrating Massage Roller: LOOKEE A10 Massage Mat: RN CA43117 Mini Vibrating ball: SM-412 Electric Shower Brush: SM-416 NECK THERAPY PRO: 1001100082 Massage Mattress Massage Cushion: SM-602,SM-603,SM-604,SM-213 Neck and Shouler Massager+SM-115;Slimming Belt+SM- 307;Heating Pad Massager with Vibration+SM-308 Agility Mini Vibrating ball: SM-412DB Cellulite Massager+SM-405;Vibrating Massage Roller+LOOKEE A10;Vibration Ball+MG10/ PP410 Cellulite Massager: SM-405 ELECTRO STIMULATION HEATED NECK PAIN RELIEVER: SM-J60 Shinbox Cordless Foot Massager with Heat and Compression 4 Node Heads Massager Buffer+SM-405;Mini Massager Gun+SM-452;Eye Mask Massager+SM-701 ThermoVibe Eye Massager+SM-705B

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2017-07-17
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2022-08-01

Official Correspondent

Qinyi Wang

US Agent Details

Kai Li Email: likai323@hotmail.com Phone: (501) 7778490

Related Public Records

Same Entity

Xiamen Simo Electronic 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

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3030407739	CL MEDIX INC	Chantilly, VA, US
3009079475	Aerotel Ltd.	Holon Central, IL
3025350087	LENYO WORLD LTD	Budapest, HU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013733364. Last updated year: 2026. Please use registration number 3013733364 when referencing this establishment in official correspondence.