Primo
Bath System - Prim Sys23 HM&SV P200+ DispDes
4manufacturers in China registered for this device type
281catalogue 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 | 2017-02-19 |
| 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 |
|---|---|---|
| AP35811US20100 | In distribution | |
| AP33202US0011 | In distribution | |
| AP31801US0011 | In distribution | |
| AP31212US2000 | In distribution | |
| AP31200US0010 | In distribution | |
| AP03811US0010 | In distribution | |
| AP32212US0100 | In distribution | |
| AP32811US1001 | In distribution | |
| AP32212US1010 | In distribution | |
| AP32311US2111 | In distribution | |
| AP33202US2000 | In distribution | |
| AP31202US2001 | In distribution | |
| AP32312US2111 | In distribution | |
| AP31811US1001 | In distribution | |
| AP33202US1001 | In distribution | |
| AP02801US1010 | In distribution | |
| AP05811US10100 | In distribution | |
| AP31202US1000 | In distribution | |
| AP33801US1010 | In distribution | |
| AP02211US0001 | In distribution | |
| AP03312US0010 | In distribution | |
| AP31202US0011 | In distribution | |
| AP31800US1000 | In distribution | |
| AP32211US1101 | In distribution | |
| AP33212US0001 | In distribution | |
| AP33811US0001 | In distribution | |
| AP32211US1100 | In distribution | |
| AP01202US0010 | In distribution | |
| AP03212US0001 | In distribution | |
| AP33311US2010 | In distribution | |
| AP32211US2001 | In distribution | |
| AP33202US2011 | In distribution | |
| AP33202US0000 | In distribution | |
| AP31202US0010 | In distribution | |
| AP31202US1010 | In distribution | |
| AP02211US2000 | In distribution | |
| AP32211US0010 | In distribution | |
| AP31212US1001 | In distribution | |
| AP33811US1000 | In distribution | |
| AP31811US2001 | In distribution | |
| AP33211US0010 | In distribution | |
| AP31811US1011 | In distribution | |
| AP32212US1011 | In distribution | |
| AP32312US0110 | In distribution | |
| AP31811US1000 | In distribution | |
| AP32311US1111 | In distribution | |
| AP32212US1110 | In distribution | |
| AP02811US1001 | In distribution | |
| AP31202US1001 | In distribution | |
| AP02211US2001 | In distribution | |
| AP31800US1010 | In distribution | |
| AP03312US1011 | In distribution | |
| AP03811US0011 | In distribution | |
| AP32211US0101 | In distribution | |
| AP33200US0010 | In distribution | |
| AP02211US2100 | In distribution | |
| AP03811US2010 | In distribution | |
| AP32811US2011 | In distribution | |
| AP03312US2010 | In distribution | |
| AP33801US1000 | In distribution | |
| AP31801US2000 | In distribution | |
| AP32811US1010 | In distribution | |
| AP02811US2001 | In distribution | |
| AP03811US1000 | In distribution | |
| AP32211US0100 | In distribution | |
| AP02211US2010 | In distribution | |
| AP32202US1010 | In distribution | |
| AP31202US2010 | In distribution | |
| AP32811US0010 | In distribution | |
| AP03212US2011 | In distribution | |
| AP02811US0001 | In distribution | |
| AP31800US2000 | In distribution | |
| AP33811US1010 | In distribution | |
| AP31212US1010 | In distribution | |
| AP33312US2010 | In distribution | |
| AP33811US2011 | In distribution | |
| AP32211US2101 | In distribution | |
| AP03811US2001 | In distribution | |
| AP03212US0010 | In distribution | |
| AP32211US1010 | In distribution | |
| AP33311US2011 | In distribution | |
| AP03212US1001 | In distribution | |
| AP31212US1000 | In distribution | |
| AP32212US0010 | In distribution | |
| AP32211US1111 | In distribution | |
| AP03312US0011 | In distribution | |
| AP02211US2110 | In distribution | |
| AP02211US1010 | In distribution | |
| AP32212US0000 | In distribution | |
| AP32212US2101 | In distribution | |
| AP31212US2011 | In distribution | |
| AP32311US2110 | In distribution | |
| AP02811US1000 | In distribution | |
| AP03212US1000 | In distribution | |
| AP32212US1100 | In distribution | |
| AP33811US2001 | In distribution | |
| AP32311US1110 | In distribution | |
| AP32811US0011 | In distribution | |
| AP03212US2010 | In distribution | |
| AP03212US2001 | In distribution | |
| AP33801US0010 | In distribution | |
| AP33801US0001 | In distribution | |
| AP32311US0111 | In distribution | |
| AP31801US1010 | In distribution | |
| AP02211US0011 | In distribution | |
| AP33212US2011 | In distribution | |
| AP31811US2000 | In distribution | |
| AP32212US2100 | In distribution | |
| AP01212US1010 | In distribution | |
| AP03811US0000 | In distribution | |
| AP32211US2010 | In distribution | |
| AP32801US1000 | In distribution | |
| AP32212US1000 | In distribution | |
| AP02811US0000 | In distribution | |
| AP32811US1000 | In distribution | |
| AP33312US0010 | In distribution | |
| AP01811US1010 | In distribution | |
| AP33312US1010 | In distribution | |
| AP31212US2010 | In distribution | |
| AP32212US2001 | In distribution | |
| AP31801US2011 | In distribution | |
| AP33311US0010 | In distribution | |
| AP33202US1010 | In distribution | |
| AP32212US2111 | In distribution | |
| AP31212US1011 | In distribution | |
| AP31811US0000 | In distribution | |
| AP02211US0111 | In distribution | |
| AP33202US2001 | In distribution | |
| AP32211US0001 | In distribution | |
| AP31801US1001 | In distribution | |
| AP31212US2001 | In distribution | |
| AP31800US2011 | In distribution | |
| AP33311US1011 | In distribution | |
| AP31800US0010 | In distribution | |
| AP33811US0010 | In distribution | |
| AP31800US0011 | In distribution | |
| AP02811US0010 | In distribution | |
| AP32211US2000 | In distribution | |
| AP31212US0001 | In distribution | |
| AP02211US2101 | In distribution | |
| AP03811US2011 | In distribution | |
| AP31801US2010 | In distribution | |
| AP32212US0111 | In distribution | |
| AP31811US0010 | In distribution | |
| AP31811US1010 | In distribution | |
| AP33311US0011 | In distribution | |
| AP02211US0110 | In distribution | |
| AP02311US0111 | In distribution | |
| AP03811US0001 | In distribution | |
| AP01811US0011 | In distribution | |
| AP03212US0011 | In distribution | |
| AP32211US2011 | In distribution | |
| AP02811US2000 | In distribution | |
| AP33202US2010 | In distribution | |
| AP02211US0101 | In distribution | |
| AP02211US2011 | In distribution | |
| AP02211US1001 | In distribution | |
| AP32312US2110 | In distribution | |
| AP32212US1111 | In distribution | |
| AP33212US1000 | In distribution | |
| AP33212US2001 | In distribution | |
| AP32212US2010 | In distribution | |
| AP03312US2011 | In distribution | |
| AP32212US2110 | In distribution | |
| AP31202US2000 | In distribution | |
| AP33312US2011 | In distribution | |
| AP32212US1001 | In distribution | |
| AP03811US2000 | In distribution | |
| AP32212US1101 | In distribution | |
| AP32801US2001 | In distribution | |
| AP33311US1010 | In distribution | |
| AP33811US2000 | In distribution | |
| AP32211US2111 | In distribution | |
| AP31801US0001 | In distribution | |
| AP02211US1011 | In distribution | |
| AP01801US1001 | In distribution | |
| AP32211US2100 | In distribution | |
| AP33801US2000 | In distribution | |
| AP31202US2011 | In distribution | |
| AP33202US0001 | In distribution | |
| AP02811US1010 | In distribution | |
| AP32811US0000 | In distribution | |
| AP31800US2010 | In distribution | |
| AP02811US1011 | In distribution | |
| AP32211US1011 | In distribution | |
| AP31811US2010 | In distribution | |
| AP33212US0011 | In distribution | |
| AP02811US2011 | In distribution | |
| AP33312US0011 | In distribution | |
| AP03811US1001 | In distribution | |
| AP03212US0000 | In distribution | |
| AP32211US1000 | In distribution | |
| AP32212US0101 | In distribution | |
| AP32811US2000 | In distribution | |
| AP31801US0000 | In distribution | |
| AP32211US1110 | In distribution | |
| AP32211US0110 | In distribution | |
| AP03212US1011 | In distribution | |
| AP32312US1111 | In distribution | |
| AP32811US2010 | In distribution | |
| AP33801US2001 | In distribution | |
| AP32312US1110 | In distribution | |
| AP31801US1000 | In distribution | |
| AP33811US2010 | In distribution | |
| AP32211US0000 | In distribution | |
| AP33312US1011 | In distribution | |
| AP33801US2011 | In distribution | |
| AP02211US1100 | In distribution | |
| AP31202US1011 | In distribution | |
| AP02211US0100 | In distribution | |
| AP31800US1011 | In distribution | |
| AP32311US0011 | In distribution | |
| AP31212US0000 | In distribution | |
| AP03811US1011 | In distribution | |
| AP03811US1010 | In distribution | |
| AP31212US0010 | In distribution | |
| AP32212US2000 | In distribution | |
| AP31202US0001 | In distribution | |
| AP31801US2001 | In distribution | |
| AP32212US0110 | In distribution | |
| AP31801US0010 | In distribution | |
| AP31811US0011 | In distribution | |
| AP33801US0000 | In distribution | |
| AP31811US2011 | In distribution | |
| AP31202US0000 | In distribution | |
| AP03801US0011 | In distribution | |
| AP32212US0011 | In distribution | |
| AP31800US0001 | In distribution | |
| AP03212US1010 | In distribution | |
| AP33202US1011 | In distribution | |
| AP32312US0111 | In distribution | |
| AP02211US0000 | In distribution | |
| AP03311US0011 | In distribution | |
| AP33811US1001 | In distribution | |
| AP02211US2111 | In distribution | |
| AP02211US0010 | In distribution | |
| AP33801US1011 | In distribution | |
| AP31800US0000 | In distribution | |
| AP02811US0011 | In distribution | |
| AP32211US1001 | In distribution | |
| AP33212US2000 | In distribution | |
| AP33811US1011 | In distribution | |
| AP02211US1111 | In distribution | |
| AP33202US1000 | In distribution | |
| AP31801US1011 | In distribution | |
| AP02211US1000 | In distribution | |
| AP03801US1010 | In distribution | |
| AP33801US1001 | In distribution | |
| AP32211US0011 | In distribution | |
| AP02211US1101 | In distribution |
Showing 250 of 281 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.