CRYOTherm
Immersion hydrobath.
4manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Since Household Care Co., Ltd. | Dongguan | Guangdong | Manufacturer | 11 |
| Guangdong Titan Smart Electrical Appliance Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 10 |
| Shenzhen Margotan Tech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 10 |
| Dongguan Jifan Electric Appliance Co., Ltd. | Dongguan | Guangdong | Manufacturer | 7 |
Record
| Listed by | Grimm Scientific Industries, Inc., United States |
|---|---|
| FDA product code | ILJ |
| Device type | Bath, Hydro-Massage |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5100 |
| Record published | 2016-08-14 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CRYOTherm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Primo | Arjohuntleigh AB | 281 |
| Hydrotherapy Whirlpool | Whitehall Manufacturing Co | 223 |
| Freedom Bath | Arjohuntleigh AB | 103 |
| Harmony Bath | Arjohuntleigh AB | 84 |
| Primo Ferro | Arjohuntleigh AB | 60 |
| Symbliss Bath | Arjohuntleigh AB | 56 |
| Whirlpool Turbine | Whitehall Manufacturing Co | 30 |
| Rhapsody | Arjohuntleigh AB | 29 |
| Parker Bath | Arjohuntleigh AB | 11 |
| Invacare® TheraPure™ Bathing Systems | Invacare GmbH | 8 |
| Apollo Corp | Apollo Corp. | 6 |
| Century | Arjohuntleigh AB | 3 |
Showing 12 of 41. All products under Bath, Hydro-Massage
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K864721 | 1987-02-04 |
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.