Primo Ferro
Bath System - Primo Ferro, Sys23, Hydrosound
4manufacturers in China registered for this device type
60catalogue numbers in this listing
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 | Arjohuntleigh AB, Sweden |
|---|---|
| FDA product code | ILJ |
| Device type | Bath, Hydro-Massage |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5100 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2016-10-28 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AS33311-US | In distribution | |
| AS52302US0010 | In distribution | |
| AS33801US0010 | In distribution | |
| AS32212US0110 | In distribution | |
| AS33312US0010 | In distribution | |
| AS33212US0000 | In distribution | |
| AS32212-US | In distribution | |
| AS52212US0000 | In distribution | |
| AS52801US0000 | In distribution | |
| AS52302-US | In distribution | |
| AS32202-US | In distribution | |
| AS52212US0010 | In distribution | |
| AS52312US0110 | In distribution | |
| AS33212US0001 | In distribution | |
| AS32212US0101 | In distribution | |
| AS52212US0100 | In distribution | |
| AS52212US0111 | In distribution | |
| AS52212US0001 | In distribution | |
| AS33212US0010 | In distribution | |
| AS33212US0011 | In distribution | |
| AS32202US0000 | In distribution | |
| AS32202US0011 | In distribution | |
| AS32212US0011 | In distribution | |
| AS32202US0110 | In distribution | |
| AS32312US0110 | In distribution | |
| AS52212US0110 | In distribution | |
| AS32212US0001 | In distribution | |
| AS32202US0001 | In distribution | |
| AS32312US0010 | In distribution | |
| AS32312-US | In distribution | |
| AS52212US0011 | In distribution | |
| AS33312US0011 | In distribution | |
| AS52302US0110 | In distribution | |
| AS32212US0100 | In distribution | |
| AS33302US0010 | In distribution | |
| AS52302US0111 | In distribution | |
| AS32312US0011 | In distribution | |
| AS52302US0011 | In distribution | |
| AS32801US0000 | In distribution | |
| AS33811US0010 | In distribution | |
| AS32202US0111 | In distribution | |
| AS53312-US | In distribution | |
| AS33311US0011 | In distribution | |
| AS33311US0010 | In distribution | |
| AS32212US0000 | In distribution | |
| AS33212-US | In distribution | |
| AS52212-US | In distribution | |
| AS52212US0101 | In distribution | |
| AS32302US0110 | In distribution | |
| AS32202US0010 | In distribution | |
| AS53312US0011 | In distribution | |
| AS33811US0011 | In distribution | |
| AS32202US0101 | In distribution | |
| AS32312US0111 | In distribution | |
| AS52202US0010 | In distribution | |
| AS32212US0111 | In distribution | |
| AS53312US0010 | In distribution | |
| AS32202US0100 | In distribution | |
| AS53212US0010 | In distribution | |
| AS32212US0010 | 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 |
| 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 |
| Whitehall Thermalators | Whitehall Manufacturing Co | 2 |
Showing 12 of 41. All products under Bath, Hydro-Massage
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K110994 | 2011-07-06 |
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.