ManaMed
- Primary DI
- 00810113680644
- Brand
- ManaMed
- Company
- Manamed, Inc.
- Model
- ManaEZ ROM Elite
- Catalog number
- EZRE001
- Device description
- "The ManaEZ Rom Elite adjustable knee brace allows the user to adjust the length of the brace for custom fitting. This product is ideal for knee ligament damage, knee surgeries, and instability of the knee. The ManaEZ Rom Elite is designed for post-operative fixation, allowing the doctor to lock the patient into extension and control range of motion as prescribed. ManaEZ ROM Elite is a quick fitting, universal, telescoping, and drop lock post op knee brace. The brace has a unique malleable bar system to conform to all shapes and sizes.-Telescoping and malleable hinge bars extendable from 16.5"" - 27"" (42cm - 68.5cm)-Hinge range of motion adjustment: Flexion (0° - 120°) and extension (0° - 90°)-Quick lock key offers ability to control and lock out the hinge motion to 0°, 15°, and 30° directly-Lightweight, latex free breathable material-Easy application, universal size with hook and buckle closure, design fits either leg"
- Published
- 2022-06-21
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- OTC
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| ITQ | Joint, Knee, External Brace |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| ITQ | Joint, Knee, External Brace | Physical Medicine | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00810113680644 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00810113680644 | 00810113680644 | 810113680644 | 0810113680644 |
GMDN Terms#
| Term | Definition |
|---|---|
| Knee orthosis | A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the knee; it may incorporate hinges for improved support. This is a reusable device. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 888-508-0712 | support@manamed.com |
Regulatory Flags#
- DUNS number
- 084042331
- Device count
- 1
- Premarket exempt
- true
- Lot or batch
- true
- Manufacturing date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00810113688473 | ManaMed Inc | ManaMed Ultrasound Coupling Gel | MANAGEL01 | 2022-12-31 |
| 00810113684154 | ManaEZ Wrist Left, Extra Large | EZW3908L-XL | EZW3908L-XL | 2025-10-17 |
| 00810113684161 | ManaEZ Wrist Left, Extra Small | EZW3908L-XS | EZW3908L-XS | 2025-10-17 |
| 00810113684178 | ManaEZ Wrist Right, Extra Large | EZW3908R-XL | EZW3908R-XL | 2025-10-17 |
| 00810113684185 | ManaEZ Wrist Right, Extra Small | EZW3908R-XS | EZW3908R-XS | 2025-10-17 |
| 00810113682969 | "ManaEZ Single Panel Knee Immobilizer 18""" | EZIMM01-18 | EZIMM01-18 | 2025-11-25 |
| 00810113682976 | "ManaEZ Single Panel Knee Immobilizer 20""" | EZIMM01-20 | EZIMM01-20 | 2025-11-25 |
| 00810113682983 | "ManaEZ Single Panel Knee Immobilizer 24""" | EZIMM01-24 | EZIMM01-24 | 2025-11-25 |
| 00810113682990 | "ManaEZ 3 Panel Knee Immobilizer 18""" | EZ3PIMM01-18 | EZ3PIMM01-18 | 2025-11-25 |
| 00810113683003 | "ManaEZ 3 Panel Knee Immobilizer 20""" | EZ3PIMM01-20 | EZ3PIMM01-20 | 2025-11-25 |
| 00810113683010 | "ManaEZ 3 Panel Knee Immobilizer 24""" | EZ3PIMM01-24 | EZ3PIMM01-24 | 2025-11-25 |
| 00810113683294 | "ManaEZ 3 Panel Knee Immobilizer 16""" | EZ3PIMM01-16 | EZ3PIMM01-16 | 2025-11-25 |
| 00810113682600 | ManaMed Inc | ManaEZ Ice Wrist | EZIWST01 | 2022-10-13 |
| 00850998008119 | ManaMed | ManaEZ Wrist Universal Right | EZW3908R | 2022-06-20 |
| 00850998008126 | ManaMed | ManaEZ Wrist Universal Left | EZW3908L | 2022-06-20 |
| 00810113683065 | ManaEZ ROM Ice Short | EZR001-XSM | EZR001-XSM | 2025-10-17 |
| 00810113683515 | ManaEZ Hip Ice CureTech | EZHIP01B-CT | EZHIP01B-CT | 2025-10-03 |
| 00810113683522 | ManaEZ ROM Ice CureTech | EZR001-CT | EZR001-CT | 2025-10-03 |
| 00810113683539 | ManaEZ Shoulder Ice CureTech | EZSHLD-CT | EZSHLD-CT | 2025-10-03 |
| 00810113683577 | ManaEZ Ice Long Duration Knee | EZLDIP-KN | EZLDIP-KN | 2025-11-25 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00057475210434 | BIOS Living | Thermor Ltd | ITQ | 2023-03-31 |
| 00609271200135 | 16'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271200159 | 16'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271200173 | 16'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271200180 | 16'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271200197 | 16'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271200333 | 20'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271200357 | 20'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271200371 | 20'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271200388 | 20'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271200395 | 20'' DLX POST-OP KNEE IMMOB | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271210509 | 20'' DLX 3-PANEL KNEE IMMOB | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271210608 | 20'' DLX 3-PANEL KNEE IMMOB | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271210806 | 20'' DLX 3-PANEL KNEE IMMOB | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610774 | "Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (small)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610781 | "Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (medium)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610798 | "Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (large)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610804 | "Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (x-large)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610811 | "Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (small)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610828 | "Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (medium)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610835 | "Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (large)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610842 | "Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (x-large)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610859 | "Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (xx-large)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610866 | "Knee Immobilizer, Super-Lite, Contoured Stay, 20"" (small)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610873 | "Knee Immobilizer, Super-Lite, Contoured Stay, 20"" (x-large)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610880 | "Knee Immobilizer, Super-Lite, Contoured Stay, 20"" (xx-large)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610897 | "Knee Immobilizer, Super-Lite, Contoured Stay, 24"" (small)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610903 | "Knee Immobilizer, Super-Lite, Contoured Stay, 24"" (medium)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610910 | "Knee Immobilizer, Super-Lite, Contoured Stay, 24"" (large)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |
| 00609271610927 | "Knee Immobilizer, Super-Lite, Contoured Stay, 24"" (x-large)" | DARCO INTERNATIONAL, INC. | ITQ | 2023-02-08 |