Vive
Abdominal Binder (4 Panel) Medium
2manufacturers in China registered for this device type
18catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan Supercare Medical Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 41 |
| Ningbo MPF Manufacturing Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 35 |
Record
| Listed by | Vive Health LLC, United States |
|---|---|
| FDA product code | FQK |
| Device type | Binder, Perineal |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5160 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-11-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Packaging | Case of 20, case of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SUP3013BLKXL2P | In distribution | |
| SUP3013BLK2XL2P | In distribution | |
| SUP3013BLKM4P | In distribution | |
| SUP3013BLKS2P | In distribution | |
| SUP3013BLK3XL4P | In distribution | |
| SUP3013BLKL3P | In distribution | |
| SUP3013BLKM3P | In distribution | |
| SUP3013BLK3XL3P | In distribution | |
| SUP3013BLKL4P | In distribution | |
| SUP3013BLKXL3P | In distribution | |
| SUP3013BLKS4P | In distribution | |
| SUP3013BLK3XL2P | In distribution | |
| SUP3013BLKXL4P | In distribution | |
| SUP3013BLK2XL4P | In distribution | |
| SUP3013BLKL2P | In distribution | |
| SUP3013BLKS3P | In distribution | |
| SUP3013BLK2XL3P | In distribution | |
| SUP3013BLKM2P | In distribution |
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.