Data / Medical devices / China / Xiamen Simo Electronic Co., Ltd
Xiamen Simo Electronic Co., Ltd: FDA-registered device maker in Xiamen Fujian, China, 1 510(k) clearance
Xiamen Simo Electronic Co., Ltd is registered with the FDA (registration 3013733364) in Xiamen Fujian, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 19, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013733364
- Address
- Floor 2 -3 1st Building No.17 North Tongsheng 2nd Rd, Tongan District, Xiamen Fujian, China, 361100
- Owner or operator
- Xiamen Simo Electronic Co., Ltd (10055384)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- July 17, 2017
- Registered through
- 2026
- Brand names listed
- 4 Node Heads Massager Buffer+SM-405;Mini Massager Gun+SM-452;Eye Mask Massager+SM-701, AIR COMPRESSION BOOTS+SM-526;Leg Air Compressor+SM-527, Agility Mini Vibrating ball: SM-412DB, Care Recovery Care Relax: SM-519/SM-523, 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;Electric Shower Brush+SM-416, ELECTRO STIMULATION HEATED NECK PAIN RELIEVER: SM-J60 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Powered Inflatable Tube | IRP | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 19, 2022 | K212935 | Air Pressure Foot Massager | IRP | Substantially Equivalent | Xiamen Simo Electronic Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated February 19, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.