ThermaCare HeatWraps
Thermacare Neck/Shoulder/Wrist 8CT + Lower Back & HIP 1CT
176manufacturers in China registered for this device type
19catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Zhejiang (39), Jiangsu (38), Guangdong (21). 22 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Yiwu Haoding Medical Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 23 |
| Guangzhou Xinbo Electronic Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 18 |
| Anhui Kangfu Industrial Foreign Trade Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 18 |
| Wuhan Huawei Technology Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 16 |
| Zhejiang Changdi Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 16 |
| Jiangsu Classic NEW-Type Medical Products Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 13 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Hanghai Medical Products Co Ltd | Jinhua | Zhejiang | Contract manufacturer | 10 |
Showing 12 of 176. All 176 manufacturers in China registered for Pack, Hot Or Cold, Disposable
Record
| Listed by | Pfizer Inc, United States |
|---|---|
| FDA product code | IMD |
| Device type | Pack, Hot Or Cold, Disposable |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5710 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-05-29 |
| Record revised | 2020-12-17 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2020-11-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ThermaCare HeatWraps – Lower Back & Hip | Withdrawn | |
| ThermaCare HeatWraps – Muscle & Joint | Withdrawn | |
| ThermaCare HeatWraps – Lower Back & Hip | Withdrawn | |
| ThermaCare HeatWraps – Neck, Wrist & Shoulder | Withdrawn | |
| ThermaCare HeatWraps – Neck, Wrist & Shoulder | Withdrawn | |
| ThermaCare HeatWraps – Lower Back & Hip | Withdrawn | |
| ThermaCare HeatWraps – Lower Back & Hip | Withdrawn | |
| ThermaCare HeatWraps – Flexible | Withdrawn | |
| ThermaCare HeatWraps – Lower Back & Hip | Withdrawn | |
| ThermaCare HeatWraps – Lower Back & Hip | Withdrawn | |
| ThermaCare HeatWraps – Neck, Wrist & Shoulder | Withdrawn | |
| ThermaCare HeatWraps – Neck, Wrist & Shoulder | Withdrawn | |
| ThermaCare HeatWraps – Flexible | Withdrawn | |
| ThermaCare HeatWraps – Menstrual | Withdrawn | |
| ThermaCare HeatWraps – Muscle & Joint | Withdrawn | |
| ThermaCare HeatWraps – Menstrual | Withdrawn | |
| ThermaCare HeatWraps – Muscle & Joint | Withdrawn | |
| ThermaCare HeatWraps – Lower Back & Hip | Withdrawn | |
| ThermaCare HeatWraps – Neck, Wrist & Shoulder | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ANF Therapy® | Amino Frequency Corporation SL. | 47 |
| Cardinal Health | Cardinal Health 200, LLC | 44 |
| Medline | Medline Industries, Inc. | 24 |
| Halyard | Owens & Minor Distribution, Inc. | 15 |
| DeRoyal | Deroyal Industries, Inc. | 14 |
| Halyard | O&M Halyard, Inc. | 14 |
| McKesson | Mckesson Medical-Surgical Inc. | 13 |
| HCS | Dyad Medical Sourcing, LLC | 13 |
| Novaplus | Cardinal Health 200, LLC | 13 |
| Curaplex | Bound Tree Medical, LLC | 13 |
| MediChoice | Owens & Minor Distribution, Inc. | 11 |
| PremierPro | Prestige Ameritech | 9 |
Showing 12 of 150. All products under Pack, Hot Or Cold, Disposable
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-10-02 | Class II | Device Design | The firm received complaints of the wrap coming apart and leaking granular material | 293880 units | 2023-08-28 |
| 2018-10-02 | Class II | Device Design | The firm received complaints of the wrap coming apart and leaking granular material | 4956 units | 2023-08-28 |
| 2018-10-02 | Class II | Device Design | The firm received complaints of the wrap coming apart and leaking granular material | 119232 units | 2023-08-28 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.