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…

Registry build 21.09.26

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.

39manufacturers in China registered for this device type
42catalogue numbers in this listing

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.

Chinese manufacturers registered for FDA product code IPY
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

Regulatory record for M-Brace Air
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

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 numbers for M-Brace Air
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

Other products under the same FDA 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer