CTC-7
Main Device 1ea, One Person Use Ankle Wrap 1ea, One Person Use Knee Wrap 1ea, One Person Use Shoulder Wrap 1ea, One Person Use Elbow Wrap 1ea, One Person Use Back Wrap 1ea, One Person Use…
Main Device 1ea, One Person Use Ankle Wrap 1ea, One Person Use Knee Wrap 1ea, One Person Use Shoulder Wrap 1ea, One Person Use Elbow Wrap 1ea, One Person Use Back Wrap 1ea, One Person Use Universal Wrap(M) 1ea, One Person Use Universal Wrap(L) 1ea, Tubing 1ea, Assist Band 1ea, Recovery Bag 1ea [One Set Box]
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 | Daesung Maref Co., Ltd., South Korea |
|---|---|
| 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 |
| Premarket notification | Exempt |
| Record published | 2021-06-15 |
| Record revised | 2023-12-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Box of 10, box of 5, box of 20, box of 40, box of 30, box of 80 |
| Distribution end date | 2021-12-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CTCSM00 | In distribution | |
| CTC7100-RRF | In distribution | |
| CTC7200 | In distribution | |
| CTCEFD0 | In distribution | |
| CTC7100-RDT | In distribution | |
| CTC7200-RP | In distribution | |
| CTC7101-RR-KUL | In distribution | |
| CTCBF00 | In distribution | |
| CTCSET-DT | In distribution | |
| CTC7101-RRF | In distribution | |
| CTCKF00 | In distribution | |
| CTC7101-RDT | In distribution | |
| CTCULD0 | In distribution | |
| CTCEF00 | In distribution | |
| CTC7101-RR-KUM | In distribution | |
| CTCAS00 | In distribution | |
| CTCKFD0 | In distribution | |
| CTC7101-DT | In distribution | |
| CTCSET | In distribution | |
| CTCSET-D | In distribution | |
| CTCUMD0 | In distribution | |
| CTC7201-RL | In distribution | |
| CTC7201-RFL-D | In distribution | |
| CTCUXD0 | In distribution | |
| CTCAF00 | In distribution | |
| CTC7100-RR-KUM | In distribution | |
| CTC7201-0 | In distribution | |
| CTCSMD0 | In distribution | |
| CTC7101 | In distribution | |
| CTC7100-DT | In distribution | |
| CTC7100 | In distribution | |
| CTCUM00 | In distribution | |
| CTCHFR0 | In distribution | |
| CTCSET-RT | In distribution | |
| CTC7201-RM | In distribution | |
| CTC7101-RDF | In distribution | |
| CTCAFD0 | In distribution | |
| CTCUL00 | In distribution | |
| CTC7201 | In distribution | |
| CTC7100-RR-KUL | In distribution | |
| CTC7201-RFM-D | In distribution | |
| CTC7201-RP | In distribution | |
| CTC7100-RDF | In distribution | |
| CTCBFD0 | In distribution | |
| CTCHFL0 | In distribution | |
| CTC7210 | In distribution | |
| CTCKFA0 | Withdrawn | |
| CTCAFDA | Withdrawn | |
| CTCAFA0 | Withdrawn | |
| CTCUMW0 | Withdrawn | |
| CTCEFDA | Withdrawn | |
| CTCAFW0 | Withdrawn | |
| CTCBFW0 | Withdrawn | |
| CTCBFDA | Withdrawn | |
| CTCSMDA | Withdrawn | |
| CTCUMA0 | Withdrawn | |
| CTCULW0 | Withdrawn | |
| CTCEFA0 | Withdrawn | |
| CTCSMA0 | Withdrawn | |
| CTCKFW0 | Withdrawn | |
| CTCULA0 | Withdrawn | |
| CTCULDA | Withdrawn | |
| CTCUMDA | Withdrawn | |
| CTCKFW0 | Withdrawn | |
| CTCBFA0 | Withdrawn | |
| CTCKFDA | Withdrawn | |
| CTCEFW0 | Withdrawn |
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 |
| 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 |
| Polar Products | Polar Products Inc | 18 |
Showing 12 of 153. All products under Pack, Hot Or Cold, Water Circulating
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.