FDA UDI
In Commercial Distribution
🇺🇸 United States
Jenx
DI: 05056235206019
·
Model: LY01 014
·
JENX LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Jenx
- Primary DI
- 05056235206019
- Version / Model
- LY01 014
- Company Name
- JENX LIMITED
- Labeler DUNS
- 291659639
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-29
- Public Version
- 1
- Public Version Date
- 2023-10-09
- Public Version Status
- New
- Public Device Record Key
- bd9caa12-91f3-4571-bac7-9724d0a6b76f
Device Description
Ly-On Accessory Mount
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| INW | Table, Mechanical | Physical Medicine | 890.3750 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13964 | Physical therapy table, non-powered | A dedicated device specifically designed for use in physical therapies. It is a non-powered device that has manually-adjustable table top functions for height and position, including vertical tilting from supine to upright. It will typically incorporate foot supports, straps and exercisers (e.g., pulleys or rotators, arm slings, and leg exercisers). This device is designed for treatment of diseases using therapeutic exercises and massage, e.g., to enhance blood circulation to the lower limbs in patients with neurological disorders (e.g., spinal cord injury) and also to aid in muscle training and sense of balance. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05056235206019 | GS1 |