Adhesive Backed Thermal Skin Patches
Physical Medicine · 21 CFR 890.5710
Pain relief heat patches for temporary relief of muscular and joint pian assoiciated with arthritis, simple backache, muscle strains and sprains.External use only. Not on damaged skin or open sores. Do no use under the age of 12. Do use on people who are not able to feel pain. Patch is applied directly to site of pain over intact skin for up to 8 hours but not more than once in a 24 hour period. Do not use more than 7 days. Over the counter device. No prescription. Do not sleep on or put pressure on heat patch for extended period of time. Do not use with any creams or oils. Can remove body hair upon patch removal due to adhesive. Can cause burns.
Recent MDR events
46 adverse event reports on file
- HEAT PATCHESJun 17, 2026MalfunctionUnknownMW5189630
- CVS HEALTH MENSTRUAL HEAT PATCHMar 31, 2026InjuryRapid Aid Vietnam Co. Ltd1118693-2026-00001
- WALGREENS HEAT PATCHES FOR MENSTRUAL PAINFeb 24, 2026InjuryUnkMW5184374
- HEALTHPOINT COOLING GEL PATCHESFeb 23, 2026InjuryUnkMW5184191
- ASPERCREME WITH 4% LIDOCAINE PATCH /SONFIAug 14, 2025InjuryChattem Inc.MW5174548
- LIFEWAVE PATCHJun 25, 2025InjuryLifewave Inc.MW5171944
- LIFEWAVE X39, X49, AEON, GLUTHION AND CARNOSINEJun 25, 2025InjuryLifewave Inc.MW5171966
- LIVEWAVE GLUTATHIONE X39, X49, PATCHJun 17, 2025InjuryLivewave, Inc.MW5171567
- LIVEWAVE GLUTATHIONE X39, X49, PATCHJun 17, 2025InjuryLivewave, Inc.MW5171568
- LIFEWAVE X39Aug 15, 2024InjuryLifewave, Inc.MW5158515
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
74 firms currently registered for this product code
Hefei Kobayashi Daily Products Co., Ltd.
HEFEI Anhui, CN
Health Body World Supply, Inc. Dba The Wabbo Company
Lake Elsinore, CA, US
Bluemed Healthcare Co.,ltd
Shanghai, CN
Kobayashi Pharmaceutical (china) Co.,ltd.
Minhang District Shanghai, CN
Rapid Aid Corp.
MISSISSAUGA Ontario, CA
Scope Medical Devices Private Limited
Ambala City Haryana, IN
Kobayashi Pharmaceutical Co., Ltd.
Chuo-ku Osaka, JP
Rapid Aid Corp.
Wilmington, DE, US
Wuhu Qicheng New Material Co.,ltd.
Wuhu Anhui, CN
Shanghai Ruicheng Industry Co., Ltd.
Baoshan District Shanghai, CN
Taizhou Chenguang Import And Export Trading Co., Ltd.
Taizhou Jiangsu, CN
Fourstar Group Inc.
TAIPEI, TW
Rapid Aid Corp.
Moberly, MO, US
Shenzhen Yimi Care Technology Co.,ltd
Shenzhen Guangdong, CN
Nanjing 3h Medical Products Co.,ltd.
NANJING Jiangsu, CN
Yancheng Trancom First Aid Supplies Industrial Co., Ltd
Yangcheng Jiangsu, CN
Crion Corp.
Seongnam-si Gyeonggi, KR
Tao Technologies Srl Semplificata
VEDELAGO Treviso, IT
Wenzhou Shengkai Technology Industry Co.,ltd
Wenzhou city Zhejiang, CN
Rapid Aid Vietnam Co., Ltd
An Quang Commune Hai Phong, VN
Anhui Xuanwuyan Pharmaceutical Co.,ltd
Fuyang Anhui, CN
Hebei Houde Hanfang Medical Devices Group Co.,ltd
Shijiazhuang City Hebei, CN
Rusun Medical Co., Ltd
Yichun City Jiangxi, CN
Emsrun Group
Wuxi Jiangsu, CN
Jiangsu Intco Medical Products Co., Ltd.
Zhenjiang New District Jiangsu, CN
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.