Regard™
Maternity Button Hole Fetal Belt, Iniv Size
54manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (11), Jiangsu (11), Hebei (9). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 21 |
| Hengshui Tianjian Medical Supplies Co., Ltd. | Shenzhou | Hebei | Contract manufacturer | 14 |
| Jiangsu Senolo Medical Technology Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 12 |
| Zhejiang Steriger Sports Medicine Technology Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 11 |
| Planet(Shanghai) International Co., Ltd. | Shanghai | Shanghai | Exporter | 93 |
| AID United International Co., Limited | Shanghai | Shanghai | Specification developer | 65 |
| Dongguan Supercare Medical Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 41 |
| Hengshui Gangsheng Medical Instruments Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 36 |
| Ningbo MPF Manufacturing Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 35 |
| Emsrun Group | Wuxi | Jiangsu | Specification developer | 34 |
| Hangzhou Weize IMP & EXP Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 34 |
Showing 12 of 54. All 54 manufacturers in China registered for Band Or Belt, Pelvic Support
Record
| Listed by | Resource Optimization & Innovation, L.L.C. |
|---|---|
| FDA product code | ISR |
| Device type | Band Or Belt, Pelvic Support |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3025 |
| Premarket notification | Exempt |
| Record published | 2023-08-10 |
| Record revised | 2026-05-01 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Packaging | Pack of 50 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| BTNBLT-REG | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neotech Care | Neotech Care Inc. | 43 |
| ComfyHealth | Comfy Health Group Co., Ltd. | 36 |
| Vive | Vive Health LLC | 16 |
| ASP Medical | ASP Global, LLC | 9 |
| Therafit Belts | Therafin Corporation | 8 |
| Medi-Band | Medi-Tech, Inc. | 8 |
| Abdominal Binder | Dynarex Corp. | 5 |
| Emsrun | Wuxi Emsrun Technology Co., Ltd. | 3 |
| CoreTech | Vive Health LLC | 2 |
| Azmed | Hengshui Tianjian Medical Supplies Co., Ltd. | 2 |
| Comfytopia | Comfytopia, Inc. | 2 |
| Halyard | O&M Halyard, Inc. | 2 |
Showing 12 of 16. All products under Band Or Belt, Pelvic Support
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.