Halfback2-50
Halfback2-50 Lumbar-Sacral Orthosis (LSO) is designed to provide support for spinal injuries and conservative treatments of spinal injuries. Halfback50 provides superior sagittal and…
Halfback2-50 Lumbar-Sacral Orthosis (LSO) is designed to provide support for spinal injuries and conservative treatments of spinal injuries. Halfback50 provides superior sagittal and coronal control and support from T9-S1. Common Indications for Use: Low Back Pain Osteoporosis Disc Degeneration Disc Herniation Post-Operative Fusion Laminectomy Discectomy Spinal Stenosis Spondylolisthesis Features and Benefits: Low profile; lightweight Patent-pending dual-pull cord compression system Three location gear system Multiple L-Code configurations Universal sizing from 25″ to 68″
Who Else Makes It
Concentrated in Guangdong (12), Fujian (7), Jiangsu (6). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 21 |
| Yangzhou Feiyali Sporting Goods Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 15 |
| Hubei Dacheng Medical Technology Co., Ltd. | Xianning | Hubei | Contract manufacturer | 12 |
| Ningbo Regookids Accessories Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 2 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Planet(Shanghai) International Co., Ltd. | Shanghai | Shanghai | Exporter | 93 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
| Planet (Anhui) International Co., Ltd. | Chuzhou | Anhui | Exporter | 80 |
| AID United International Co., Limited | Shanghai | Shanghai | Specification developer | 65 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Dongguan Supercare Medical Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 41 |
Showing 12 of 39. All 39 manufacturers in China registered for Orthosis, Lumbo-Sacral
Record
| Listed by | Manamed LLC, United States |
|---|---|
| FDA product code | IPY |
| Device type | Orthosis, Lumbo-Sacral |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3490 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-09-19 |
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 |
|---|---|---|
| HB050-2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 359 |
| M-Brace Air | Indaco SRL | 42 |
| Wellbrace | Pantymed S.A. | 29 |
| Activday | Indaco SRL | 21 |
| Sacroiliac Belt | Medical Specialties, Inc. | 9 |
| Back-N-Black | Medical Specialties, Inc. | 7 |
| Back-N-Black Low Profile | Medical Specialties, Inc. | 7 |
| Back-n-Black with Thermo Pocket | Medical Specialties, Inc. | 6 |
| Archimed 627 Spinal Brace | Medical Specialties, Inc. | 6 |
| Archimed 637 Spinal Brace | Medical Specialties, Inc. | 6 |
| Back-n-Shape II | Medical Specialties, Inc. | 6 |
| Archimed 631 Spinal Brace | Medical Specialties, Inc. | 6 |
Showing 12 of 89. All products under Orthosis, Lumbo-Sacral
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.