Breg
4 catalogue numbers from EPIC LP TLSO 456/457, listed by Breg, Inc., United States, under Orthosis, Thoracic. 30 manufacturers in China are registered for this product code.
30manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (9), Shanghai (4), Zhejiang (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo MPF Manufacturing Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 35 |
| Picard Healthcare Technology (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Yangzhou Juli Sports Articles Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 16 |
| Dongguan Vincent Rehab Devices Company Limited | Dongguan | Guangdong | Contract manufacturer | 11 |
| Simple Manufacturing DG Ltd | Dongguan | Guangdong | Contract manufacturer | 9 |
| 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 |
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Anhui Yibao Home Textile Co., Ltd. | Hefei | Anhui | Manufacturer | 31 |
| Hengshui Jingkang Medical Device Co., Ltd. | Hengshui | Hebei | Manufacturer | 31 |
| Tianjin Tairuibosi Medical Appliance Co., Ltd. | Tianjin | Tianjin | Private-label distributor | 30 |
Showing 12 of 30. All 30 manufacturers in China registered for Orthosis, Thoracic
Record
| Listed by | Breg, Inc., United States |
|---|---|
| FDA product code | IPT |
| Device type | Orthosis, Thoracic |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3490 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EPIC LP TLSO 456/457 | In distribution | |
| ASCEND TLSO 456/457 | In distribution | |
| PINNACLE TLSO 464 | In distribution | |
| UPGRADE KIT, PINNACLE TLSO 464 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Wellbrace | Pantymed S.A. | 26 |
| CoreTech | Vive Health LLC | 10 |
| cofoe | Cofoe Medical Technology Co., Ltd. | 9 |
| babaka | Cofoe Medical Technology Co., Ltd. | 7 |
| TM “Rehabilitimed” OT-1V L Comfort | Reabilitimed TOV | 4 |
| Trend | Orthofix US LLC | 4 |
| TM “Rehabilitimed” OT-1V Lp Comfort | Reabilitimed TOV | 4 |
| TM “Rehabilitimed” OT-1V M Comfort | Reabilitimed TOV | 4 |
| TM “Rehabilitimed” OT-1V S Comfort | Reabilitimed TOV | 4 |
| TM “Rehabilitimed” OT-1V XL Comfort | Reabilitimed TOV | 4 |
| TM “Rehabilitimed” OT-1V Sh Comfort | Reabilitimed TOV | 4 |
| TM “Rehabilitimed” OT-1V Mp Comfort | Reabilitimed TOV | 4 |
Showing 12 of 31. All products under Orthosis, Thoracic
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.