ManaMed
The Kahuna Brace provides support for shoulder surgeries in a universal multiple configuration brace. Suitable for all shoulder surgeries as well as conservative care of shoulder injuries.…
The Kahuna Brace provides support for shoulder surgeries in a universal multiple configuration brace. Suitable for all shoulder surgeries as well as conservative care of shoulder injuries. The Kahuna Brace is your new go to shoulder brace for all your clinical needs. Sized universal Low-profile design True Airplane or Gunslinger alignment Two step application Multiple abduction angles Extreme external rotation
Who Else Makes It
Concentrated in Guangdong (8), Jiangsu (5), Zhejiang (3). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hengshui Gangsheng Medical Instruments Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 36 |
| Fortune Company Ltd. | Huizhou | Guangdong | Contract manufacturer | 23 |
| Cixi Cijia Handicraft Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 7 |
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Yearstar Healthcare Technology Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 43 |
| Dongguan Supercare Medical Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 41 |
| Hangzhou Weize IMP & EXP Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 34 |
| Changzhou Meiguan Care Products Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 32 |
| Changzhou Major Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 31 |
| Hengshui Runde Medical Instruments Co., Ltd. | Hengshui | Hebei | Manufacturer | 25 |
| JKH Health Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 22 |
| Medex Medical Supplies Ltd. | China | Guangdong | Contract manufacturer | 20 |
Showing 12 of 20. All 20 manufacturers in China registered for Joint, Shoulder, External Limb Component
Record
| Listed by | Manamed LLC, United States |
|---|---|
| FDA product code | IQQ |
| Device type | Joint, Shoulder, External Limb Component |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3420 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-06-10 |
| Record revised | 2024-07-25 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Mini Kahuna Brace | In distribution | |
| Cabo Elbow Left | In distribution | |
| Cabo Elbow Right | In distribution | |
| Kahuna Brace | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tehlin | TEH LIN Prosthetic & Orthopaedic, Inc. | 35 |
| Axis | College Park Industries | 20 |
| DeRoyal | Deroyal Industries, Inc. | 10 |
| Elite Orthopaedics | Elite Orthopaedics, Inc. | 5 |
| Trend | Orthofix US LLC | 4 |
| Copperfit | Ideavillage Products Corp. | 2 |
| ManaEZ Shoulder Ice CureTech | Manamed LLC | 1 |
| CoreTech | Vive Health LLC | 1 |
| Fullerton Manufacturing Limited | Fullerton Manufacturing Limited | 1 |
| Unite Medical® | Unite Medical, LLC | 1 |
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.