Harmony Bath
Bath System - Har Sys23 HS&SV P200+ DispDes
4manufacturers in China registered for this device type
84catalogue 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 | 2017-03-19 |
| 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 |
|---|---|---|
| AD33811US0011 | In distribution | |
| AD33811US0000 | In distribution | |
| AD33212US1011 | In distribution | |
| AD31800US0010 | In distribution | |
| AD33312US0011 | In distribution | |
| AD31811US0010 | In distribution | |
| AD33811US1011 | In distribution | |
| AD32801US1001 | In distribution | |
| AD32801US0011 | In distribution | |
| AD32801US0010 | In distribution | |
| AD33212US1010 | In distribution | |
| AD32811US2000 | In distribution | |
| AD31801US1000 | In distribution | |
| AD32811US0010 | In distribution | |
| AD33801US1010 | In distribution | |
| AD31212US0010 | In distribution | |
| AD31801US2001 | In distribution | |
| AD31801US2010 | In distribution | |
| AD31811US2010 | In distribution | |
| AD33312US1011 | In distribution | |
| AD33212US0011 | In distribution | |
| AD33202US1011 | In distribution | |
| AD33811US0010 | In distribution | |
| AD32212US1010 | In distribution | |
| AD31801US1010 | In distribution | |
| AD32801US2010 | In distribution | |
| AD32801US2001 | In distribution | |
| AD31801US2000 | In distribution | |
| AD31811US1001 | In distribution | |
| AD31801US0001 | In distribution | |
| AD33800US1011 | In distribution | |
| AD32811US0001 | In distribution | |
| AD32801US1010 | In distribution | |
| AD32302US1110 | In distribution | |
| AD32312US0110 | In distribution | |
| AD31811US0011 | In distribution | |
| AD31811US1011 | In distribution | |
| AD33811US1001 | In distribution | |
| AD32811US1000 | In distribution | |
| AD31201US1010 | In distribution | |
| AD32801US0000 | In distribution | |
| AD31811US2000 | In distribution | |
| AD31811US1000 | In distribution | |
| AD36811US10100 | In distribution | |
| AD32801US2000 | In distribution | |
| AD31801US1011 | In distribution | |
| AD31801US1001 | In distribution | |
| AD31212US0011 | In distribution | |
| AD33811US2001 | In distribution | |
| AD31811US1010 | In distribution | |
| AD32811US2011 | In distribution | |
| AD31811US2001 | In distribution | |
| AD31800US0011 | In distribution | |
| AD31202US1010 | In distribution | |
| AD31811US0000 | In distribution | |
| AD32811US2010 | In distribution | |
| AD31801US2011 | In distribution | |
| AD32801US0001 | In distribution | |
| AD33811US2010 | In distribution | |
| AD31811US0001 | In distribution | |
| AD31801US0011 | In distribution | |
| AD31212US1010 | In distribution | |
| AD32811US0011 | In distribution | |
| AD33801US1011 | In distribution | |
| AD32801US1000 | In distribution | |
| AD32212US0011 | In distribution | |
| AD33811US1000 | In distribution | |
| AD33811US1010 | In distribution | |
| AD31801US0000 | In distribution | |
| AD32811US2001 | In distribution | |
| AD31811US2011 | In distribution | |
| AD31312US1010 | In distribution | |
| AD32811US1001 | In distribution | |
| AD32801US1011 | In distribution | |
| AD33811US0001 | In distribution | |
| AD31801US0010 | In distribution | |
| AD31800US1000 | In distribution | |
| AD33811US2011 | In distribution | |
| AD32801US2011 | In distribution | |
| AD32811US0000 | In distribution | |
| AD32811US1011 | In distribution | |
| AD32811US1010 | In distribution | |
| AD33811US2000 | In distribution | |
| AD31800US1010 | 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 |
| 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.