FDA UDI
In Commercial Distribution
🇺🇸 United States
Jerry
DI: 06934374100261
·
Model: JRWD6010
·
JERRY MEDICAL INSTRUMENT (SHANGHAI) CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Jerry
- Primary DI
- 06934374100261
- Version / Model
- JRWD6010
- Company Name
- JERRY MEDICAL INSTRUMENT (SHANGHAI) CO., LTD.
- Labeler DUNS
- 549752487
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-22
- Public Version
- 1
- Public Version Date
- 2021-11-01
- Public Version Status
- New
- Public Device Record Key
- 7eff348e-ae57-4afa-b4bf-1edee96aaf93
Device Description
Electric Wheelchair (Model: JRWD6010)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| ITI | Wheelchair, Powered | Physical Medicine | 890.3860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47965 | Multi-terrain sports wheelchair, electric-motor-driven | A wheeled personal mobility device incorporating a seat-support system for a person with a walking disability that is propelled by power from one or more electric motor(s) for multi-/all-terrain sports use. The electronic control of speed and manual control of direction is performed by the occupant; the wheels may include caterpillar tracks. This device is designed for unlimited off-road sports use on sand, rocky terrain, grass, snow, and/or wet ground. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06934374100261 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192739 | 000 |