Orthosis, Limb, For Back Pain
Physical Medicine · 21 CFR 890.3475
Intended to provide pressure to the soleus muscle for the purpose of temporarily reducing lower back pain that radiates down the leg associated with normal household or work activities.
Recent MDR events
3 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
16 firms currently registered for this product code
Dongguan Lee-mat Sports Technology Co., Ltd
Dongguan Guangdong, CN
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Hebei Leamai Medical Instrument Co., Ltd.
Hengshui Hebei, CN
Matana Pty Ltd
POINT COOK, Victoria, AU
Eurosirel S.p.a
Cusago Milano, IT
Yasco Enterprise Corp.
Chiayi County, TW
Sdrh Inc
Brooklyn, NY, US
Harmony Health Tech Inc
Brooklyn, NY, US
Apothecaries Sundries Mfg Pvt Ltd
GURUGRAM Haryana, IN
Miracle Medical Industries
El Obour City Al Qahirah, EG
Professional Products, Inc.
Defuniak Spgs, FL, US
Wp Sports (cambodia) Co., Ltd.
Bavet City Svay Rieng, KH
Spring Loaded Technology Incorporated
Dartmouth Nova Scotia, CA
Wellpower Sporting Goods Co., Ltd.
Dong Guan Guangdong, CN
Neomed Co., Ltd.
Saha-gu Busan, KR
Tommie Copper Inc
Mount Kisco, NY, US
510(k) clearances
1 clearances for this product code