M-Brace Air
The AIR Back Brace Low Profile acts as an immobilizing device for the lumbar-sacral region and its’ primary function is to reduce pain caused by lumbago and sciatica. Made with semi-rigid…
The AIR Back Brace Low Profile acts as an immobilizing device for the lumbar-sacral region and its’ primary function is to reduce pain caused by lumbago and sciatica. Made with semi-rigid cotton fabric, it enjoys a structure made with eight self-modeling and flexible steel stays on which a number of rigid straps slide. When the locking system is pulled and secured at the front, the inside straps stiffen the entire structure, thus effectively immobilizing the lumbar-sacral region. Two rigid thermo-formable panels for lumbar and abdominal application are included. These panels produce intra-abdominal pressure to reduce load on discs thus reducing pain and improving post-operative outcome when used with the corset in the appropriate position. The supported region extends from the sacrococcygeal joint to T-9 vertebra. Practical and easy to wear, this brace perfectly adapts to whatever size and body type, thus ensuring maximum support and comfort at the desired tension. Through a new locking technology, operated by means of two crossing bands, the closing system is totally user friendly and allows a wide range of elastic tension settings. This patented immobilizing device can be adapted to the patient’s size and body type thus resulting in a custom device. Two preliminary settings: a) for different waist or pelvis circumferences (usually only in S/M size) b) for different sizes. INDICATIONS • Lumbago, sciatica and ischialgia. • Lumbar-Sacral pain of other origin and nature. • Disc complaints. • Spondylo-arthrosis. • Osteoporosis related lumbar vertebrae complaints. • Para-vertebral lumbar muscle spasm. • Light trauma of the lumbar-sacral column. • Supports from sacrum to T-9 level. • Post-op: Following stabilizing surgery, following lumbar disk surgery. • Degenerative pathologies: Osteoporosis, lumbar- sacral vertebrae complaint, protrusions, arthritis. • Muscular pathologies: Muscular contractures. • Practical and easy to fit, it adapts perfectly to your body. • This corset acts as a corrective measure and as a support to postural defects.
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 | Indaco SRL |
|---|---|
| FDA product code | IPY |
| Device type | Orthosis, Lumbo-Sacral |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3490 |
| Premarket notification | Exempt |
| Record published | 2024-01-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Box case of 10, box-case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 594 M | In distribution | |
| 594 3XL | In distribution | |
| 584 XS | In distribution | |
| 630 L/XL | In distribution | |
| 640 | In distribution | |
| 574 4XL | In distribution | |
| 584 4XL | In distribution | |
| 627 L/XL | In distribution | |
| 574 S | In distribution | |
| 574 XS | In distribution | |
| 631 S/M | In distribution | |
| 630 2XL/3XL | In distribution | |
| 631 L/XL | In distribution | |
| 584 L | In distribution | |
| 637 S/M | In distribution | |
| 584 3XL | In distribution | |
| 584 S | In distribution | |
| 504 2XL/3XL | In distribution | |
| 594 S | In distribution | |
| 637 2XL/3XL | In distribution | |
| 642 | In distribution | |
| 503 2XL/3XL | In distribution | |
| 574 3XL | In distribution | |
| 627 S/M | In distribution | |
| 637 L/XL | In distribution | |
| 504 L/XL | In distribution | |
| 504 S/M | In distribution | |
| 584 M | In distribution | |
| 584 XXL | In distribution | |
| 574 XL | In distribution | |
| 574 L | In distribution | |
| 503 S/M | In distribution | |
| 631 2XL/3XL | In distribution | |
| 503 L/XL | In distribution | |
| 594 XL | In distribution | |
| 630 S/M | In distribution | |
| 574 M | In distribution | |
| 594 L | In distribution | |
| 627 2XL/3XL | In distribution | |
| 584 XL | In distribution | |
| 594 XXL | In distribution | |
| 574 XXL | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 359 |
| 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 |
| Orthosis Lumbar Sacral W/Standard Front Alimed | Alimed, LLC | 5 |
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.