FDA UDI
In Commercial Distribution
🇺🇸 United States
JUMPER
DI: 06951740504638
·
Model: JPD-ES100
·
Shenzhen Jumper Medical Equipment Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- JUMPER
- Primary DI
- 06951740504638
- Version / Model
- JPD-ES100
- Company Name
- Shenzhen Jumper Medical Equipment Co.,Ltd.
- Labeler DUNS
- 529217911
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-13
- Public Version
- 2
- Public Version Date
- 2019-05-23
- Public Version Status
- Update
- Public Device Record Key
- 774c561c-a071-457b-b007-29775f6a42e7
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
- Yes
- 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 |
|---|---|---|---|---|
| ISA | Massager, Therapeutic, Electric | Physical Medicine | 890.5660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61168 | Psychiatric-therapy/physical-therapy transcutaneous electrical stimulation system | A battery-powered, portable, electronic device designed to apply transcutaneous electrical stimulation to treat: 1) stress and stress-related disorders, including but not limited to anxiety, depression, and insomnia; and 2) neuromuscular symptoms (e.g., pain) and disorders typically as a form of physical therapy. It consists of a pulse generator (EPG) with separate channels for connection of a dedicated electrode/probe for each application. The device may be used in the home or in a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06951740504638 | GS1 |