Maxi-Therm®
3 catalogue numbers from 276, listed by Gentherm Medical, LLC, United States, under Pack, Hot Or Cold, Water Circulating. 45 manufacturers in China are registered for this product code.
45manufacturers in China registered for this device type
3catalogue numbers in this listing
6recalls on this code
Who Else Makes It
Concentrated in Guangdong (17), Zhejiang (6), Fujian (5). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo MPF Manufacturing Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 35 |
| Foshan Hongfeng Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 24 |
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 21 |
| Acot Plastics (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 8 |
| Dongguan Kaiser Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 7 |
| Wealthy Plastic & Electronic Products Company Limited | Huizhou | Guangdong | Contract manufacturer | 6 |
| Chengdu Cryo-Push Medical Technology Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 4 |
| Zhejiang E-Cozy Electronic Technology Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Xiamen Ortocare Sports Health Co., Ltd. | Xiamen Free Trade Zone | Fujian | Contract manufacturer | 32 |
| Hebei Ruinuo Medical Instrument Co Ltd | Shijiazhuang | Hebei | Manufacturer | 29 |
Showing 12 of 45. All 45 manufacturers in China registered for Pack, Hot Or Cold, Water Circulating
Record
| Listed by | Gentherm Medical, LLC, United States |
|---|---|
| FDA product code | ILO |
| Device type | Pack, Hot Or Cold, Water Circulating |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5720 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-08-30 |
| Record revised | 2023-12-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment temperature -40 to 122 °F; Storage environment temperature -40 to 50 °C; Handling environment temperature 59 to 107 °F; Handling environment temperature 15 to 42 °C; Storage environment humidity 20 to 95 % RH; Handling environment humidity 20 to 95 % RH |
| Packaging | Pack of 4 |
| Sizes | Weight 0.33 to 1.7 lb; length 45.7 to 154.2 cm; width 30.5 to 61 cm; width 12 to 24 in; length 18 to 60 in |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 276 | Weight 1.7 lb | 5 | In distribution |
| 273 | Width 30.5 cm | 5 | In distribution |
| 274 | Weight 0.80 lb | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 184 |
| Breg | Breg, Inc. | 135 |
| Game Ready | Avanos Medical, Inc. | 101 |
| Donjoy | DJO, LLC | 72 |
| CTC-7 | Daesung Maref Co., Ltd. | 67 |
| Aircast | DJO, LLC | 63 |
| Youwen | Shanghai Youwen Medical Technology Co., Ltd. | 55 |
| Soft-Temp | Adroit Medical Systems, Inc. | 36 |
| ThermaZone | Innovative Medical Equipment | 27 |
| Cold Rush | Ossur Americas | 22 |
| Med4 Elite | Avanos Medical, Inc. | 20 |
| Cryopush | Chengdu Cryo-Push Medical Technology Co., Ltd. | 18 |
Showing 12 of 153. All products under Pack, Hot Or Cold, Water Circulating
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-11-22 | Class II | Device Design | This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads. | 484 devices | 2023-05-08 |
| 2019-07-19 | Class III | Under Investigation by firm | Updated Manual-Warnigs have been added stating that exceeding 40’C for extended periods may cause tissue damage | 2079 units | 2020-05-13 |
| 2015-01-07 | Class II | Process design | Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak. | 1390 | 2015-06-19 |
| 2009-11-14 | Not classified | Other | Product is labeled as “Sterile”. It was observed that incomplete seals were created in the packaging materials during production. When the seal is compromised, the sterility of the product inside the package cannot be assured. | 8,872 cartons of ten + 677 each (89,397 total) | 2012-01-25 |
| 2005-01-18 | Not classified | Other | There is the potential that the power switch assembly can dislodge from the cabinet during use. | 130 devices | 2007-09-21 |
| 2005-01-18 | Not classified | Other | There is the potential that the power switch assembly can dislodge from the cabinet during use. | 553 devices. | 2007-09-21 |
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.