Sitz Bath
Sitz Bath with Attachment and instructions 2.1qt. mauve
22manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (12), Zhejiang (5), Guangdong (5). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Suzhou Texnet | Suzhou | Jiangsu | Contract manufacturer | 47 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Meifu Medical Technology Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 13 |
| JIE GAO Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Ningbo Just Soon Industrial Limited | Ningbo | Zhejiang | Repacker / relabeller | 36 |
| Ningbo Unico Products Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 35 |
| Nanjing 3H Medical Products Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 25 |
Showing 12 of 22. All 22 manufacturers in China registered for Bath, Sitz, Nonpowered
Record
| Listed by | Dynarex Corp., United States |
|---|---|
| FDA product code | KTC |
| Device type | Bath, Sitz, Nonpowered |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5125 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-09-01 |
| Record revised | 2026-03-24 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 4228 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drivemedical | Drive DeVilbiss Healthcare | 4 |
| CHS | Canadian Hospital Specialties Ltd. | 3 |
| TR900CWA HI LO 230V Cleaning, Autofill & Whirlpool GE | TR Equipment AB | 2 |
| TR Swing Bath Recling Bath TMV2 | TR Equipment AB | 2 |
| DS PrimeTaper | Dentsply Implants Manufacturing GmbH | 2 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 2 |
| Hilo Bath TR900 C TMV3 with stainless Bathtub | TR Equipment AB | 1 |
| Medtronic Cases and Trays | Medtronic Sofamor Danek, Inc. | 1 |
| TR900CA HI LO 110V Cleaning & Autofill US | TR Equipment AB | 1 |
| TR900C HI LO 230V Cleaning | TR Equipment AB | 1 |
| TR900 HI LO 230V Risk 5 TMV3 | TR Equipment AB | 1 |
| TR900 HI LO 230V GE | TR Equipment AB | 1 |
Showing 12 of 76. All products under Bath, Sitz, Nonpowered
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.