Orthosis, Sacroiliac, Soft
Pelvic Sling; Standard M
8manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Anhui (2), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Planet(Shanghai) International Co., Ltd. | Shanghai | Shanghai | Exporter | 93 |
| Planet (Anhui) International Co., Ltd. | Chuzhou | Anhui | Exporter | 80 |
| AID United International Co., Limited | Shanghai | Shanghai | Specification developer | 65 |
| Dongguan Supercare Medical Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 41 |
| Rusun Medical Co., Ltd. | Yichun | Jiangxi | Manufacturer | 37 |
| Anhui Yibao Home Textile Co., Ltd. | Hefei | Anhui | Manufacturer | 31 |
| Dongguan Redthera Technology Co., Ltd. | Dongguan | Guangdong | Repacker / relabeller | 22 |
| Kaipeng Medical Tech Development Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 12 |
Record
| Listed by | VBM Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | IPW |
| Device type | Orthosis, Sacroiliac, Soft |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3490 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-08-31 |
| Record revised | 2023-01-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: keep dry, keep away from sunlight and heat |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 34-10-005 | Circumference 110 – 140 cm | In distribution |
| 34-10-004 | Circumference 90 – 110 cm | In distribution |
| 34-10-006 | Circumference 70 – 90 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pelvic Binder | Faretec, Inc. | 9 |
| SAM Pelvic Sling II | SAM Medical Products | 4 |
| TM “Rehabilitimed” GR-3P XL Comfort | Reabilitimed TOV | 2 |
| TM “Rehabilitimed” GR-3P L Comfort | Reabilitimed TOV | 2 |
| TM “Rehabilitimed” GR-3P XXL Comfort | Reabilitimed TOV | 2 |
| TM “Rehabilitimed” GR-3P M Comfort | Reabilitimed TOV | 2 |
| TM “Rehabilitimed” GR-3P S Comfort | Reabilitimed TOV | 2 |
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.