Data / Medical devices / Bath, Hydro-Massage
Bath, Hydro-Massage (ILJ): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Bath, Hydro-Massage (product code ILJ, Class 2, 21 CFR 890.5100). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 73 510(k) clearances under this code, the latest on July 6, 2011, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- ILJ
- Device class
- 2
- Regulation
- 890.5100
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| China | 4 |
| Poland | 1 |
| United States | 1 |
| Indonesia | 1 |
Makers of Bath, Hydro-Massage
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| ArjoHuntleigh Polska Sp. zo.o. | Poznan Wielkopolskie, Poland | Complaint file establishment, Exporter to the US, Manufacturer | 4 | July 6, 2011 | 0 | 0 | 0 | api.fda.gov |
| Penner Patient Care, INC | Aurora, NE, United States | Manufacturer | 1 | April 5, 2004 | 0 | 1 | 0 | api.fda.gov |
| Dongguan Jifan Electric Appliance Co., Ltd | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Titan Smart Electrical Appliance Co., Ltd. | Zhongshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Multi Garmen Indonesia | BOGOR Jawa Barat, Indonesia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Since Household Care Co.,ltd | Dongguan City Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Margotan Tech Co., Ltd. | shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 6, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.