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Data / Medical devices / Cold Pack And Vibrating Massager

Cold Pack And Vibrating Massager (PHW): 21 FDA-registered makers in 3 countries

21 establishments in 3 countries are registered with the FDA to make Cold Pack And Vibrating Massager (product code PHW, Class 1, 21 CFR 890.5975). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on May 15, 2023, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
PHW
Device class
1
Regulation
890.5975
Medical specialty
Physical Medicine

Makers by country

CountryMakers
China18
United States2
Taiwan1

Makers of Cold Pack And Vibrating Massager

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Pain Care LabsAtlanta, GA, United StatesComplaint file establishment, Specification developer2May 15, 2023000api.fda.gov
Biboting International Co., LtdTaoyuan City, TaiwanManufacturer0000api.fda.gov
Bing Innovations LLCBoca Raton, FL, United StatesManufacturer0000api.fda.gov
Dongguan Qianhe Electronic Technology Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer, Contract sterilizer, Exporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Guangdong Fuqiang Beauty Equipment Co.,limitedQingyuan Guangdong, ChinaManufacturer0000api.fda.gov
Guangzhou Konmison Technology Co., Ltd.Guangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Hubei Xinyunqi Household Products Co., Ltd.Tongshan Hubei, ChinaManufacturer0000api.fda.gov
Health Care Massage Branch of Zhangzhou Easepal Industrial CorporationZhangzhou Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Ibe Electronics Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Jiangsu Sintang Health&technology Co.,ltdYancheng Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangsu World Biotech Co., Ltdnantong Jiangsu, ChinaManufacturer0000api.fda.gov
Shenzhen Beston E-Commerce Co., LtdShenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shenzhen Eyco Technology Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Ruiyi Business Technology Co., Ltd.Shenzhen Guangdong, ChinaExporter to the US, Manufacturer, Specification developer0000api.fda.gov
Shenzhen Saiote Intelligent Manufacturing Co., LtdShenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shenzhen Shengbanghua Technology Development Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Bway Tech Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shenzhen Margotan Tech Co., Ltd.shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Tianjin Tairuibosi Medical Appliance Co., Ltd.Tianjin, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhongshan Meiyigou Electronics Co.,ltdZhongshan Guangdong, ChinaManufacturer0000api.fda.gov
Zhongshan Bisen Plastic Electronic Products Co.,LtdZhongshan Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov

Updated May 15, 2023. 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.