FDA UDI
In Commercial Distribution
🇺🇸 United States
E.M Adams co, inc.
DI: 10840200307342
·
Model: EP26-63340XL-1
·
E.M. ADAMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- E.M Adams co, inc.
- Primary DI
- 10840200307342
- Version / Model
- EP26-63340XL-1
- Company Name
- E.M. ADAMS, INC.
- Labeler DUNS
- 001403807
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-20
- Public Version
- 1
- Public Version Date
- 2021-05-28
- Public Version Status
- New
- Public Device Record Key
- 960e444b-cbe2-49ee-b7f5-7adc9f7b4e04
Device Description
BELT
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IKX | Aid, Transfer | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58876 | Gait rehabilitation system harness | A lifting device, in the form of belts and straps, which is a component of a gait rehabilitation system designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function. The device is designed to be secured around the patient?s upper body and hips and is intended to help suspend the patient vertically over the floor or a treadmill while attached to the supporting frame of a suspension device; it may be used in conjunction with a robotic orthosis device for the training of normal gait. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50840200307333 | GS1 | Case | 48 | In Commercial Distribution | |
| Primary | 10840200307342 | GS1 |
Customer Contacts
- Phone
- +1(772)461-0532
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 2" X 72" BELT |