Primspine
PRIMSPINE MAMMY Pregnancy Girdle, gray
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan Redthera Technology Co., Ltd. | Dongguan | Guangdong | Repacker / relabeller | 22 |
| Shenzhen Tokyun Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
Record
| Listed by | Prim,s.a., Spain |
|---|---|
| FDA product code | QSB |
| Device type | Orthosis, Truncal, Pregnancy |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3490 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-03-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PRS615G OS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TM “Rehabilitimed” GL-1 L Comfort | Reabilitimed TOV | 2 |
| TM “Rehabilitimed” GL-1 Xxxl Comfort | Reabilitimed TOV | 2 |
| TM “Rehabilitimed” GL-1 S Comfort | Reabilitimed TOV | 2 |
| TM “Rehabilitimed” GL-1 XXL Comfort | Reabilitimed TOV | 2 |
| TM “Rehabilitimed” GL-1 M Comfort | Reabilitimed TOV | 2 |
| TM “Rehabilitimed” GL-1 XL 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.