M-Brace Air
- Primary DI
- 05391512286873
- Brand
- M-Brace Air
- Company
- INDACO SRL
- Model
- 139 E
- Catalog number
- 139
- Device description
- This Epicondylitis Brace (Tennis / Golfers Elbow brace) has been designed and produced as a support and protective device for tendon and joint inflammations either caused by trauma, stress or excessive fatigue. For the development of this device, two special fabrics have been matched: • The inside fabric is made from a soft breathable microfiber, extremely comfortable to the skin. • The fabric on the outside, made with a particular and dense nylon mesh forming microscopic and resistant loops, allows the Velcro to securely fasten on the surface. Due to the specific construction, this brace can be worn and positioned very easily. The tension should be adjusted taking care not to slow down the normal circulation of blood. The pressure of the inside pad, which needs to be positioned immediately below the insertion of the tendon, relieves pain by diminishing the stress on muscles, tendons and ligaments.
- Published
- 2024-02-12
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- false
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| IQI | Orthosis, Limb Brace |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| IQI | Orthosis, Limb Brace | Physical Medicine | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 05391512286873 | Package | GS1 | 24 | In Commercial Distribution |
| 05391512281939 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 05391512286873 | 05391512286873 | 5391512286873 |
| 05391512281939 | 05391512281939 | 5391512281939 |
GMDN Terms#
| Term | Definition |
|---|---|
| Elbow orthosis | A prefabricated (non-customized) externally applied and wearable orthopaedic appliance designed to encompass the elbow joint to support, align, prevent, or correct deformities/injuries or to improve function of the elbow. This is a reusable device. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 8663744050 | contact@m-brace.com |
Regulatory Flags#
- DUNS number
- 338470646
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 05391512281021 | M-Brace Air | 576 S | 576 | 2024-02-15 |
| 05391512281038 | M-Brace Air | 576 M | 576 | 2024-02-15 |
| 05391512281045 | M-Brace Air | 576 L | 576 | 2024-02-15 |
| 05391512281052 | M-Brace Air | 576 XL | 576 | 2024-02-15 |
| 05391512281441 | M-Brace Air | 576 XXL | 576 | 2024-02-15 |
| 05391512282905 | HPH Corp. | 648K size 26 | 648K | 2024-04-04 |
| 05391512282912 | HPH Corp. | 648K size 28 | 648K | 2024-04-04 |
| 05391512282929 | HPH Corp. | 648K size 30 | 648K | 2024-04-04 |
| 05391512282936 | HPH Corp. | 648K size 32 | 648K | 2024-04-04 |
| 05391512282943 | HPH Corp. | 648K size 34 | 648K | 2024-04-04 |
| 05391512282950 | HPH Corp. | 648K size 36 | 648K | 2024-04-04 |
| 05391512282967 | HPH Corp. | 648K size 38 | 648K | 2024-04-04 |
| 05391512282974 | HPH Corp. | 648K size 40 | 648K | 2024-04-04 |
| 05391512282981 | HPH Corp. | 648K size 42 | 648K | 2024-04-04 |
| 05391512282998 | HPH Corp. | 648K size 44 | 648K | 2024-04-04 |
| 05391512283001 | HPH Corp. | 648K size 46 | 648K | 2024-04-04 |
| 05391512283018 | HPH Corp. | 648K size 48 | 648K | 2024-04-04 |
| 05391512283025 | HPH Corp. | 648K size 50 | 648K | 2024-04-04 |
| 05391512283032 | HPH Corp. | 648K size 52 | 648K | 2024-04-04 |
| 05391512283049 | HPH Corp. | 648K size 54 | 648K | 2024-04-04 |
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