FDA UDI
In Commercial Distribution
🇺🇸 United States
Karma
DI: 04719873857661
·
Model: KS-747.2
·
KARMA MEDICAL PRODUCTS CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Karma
- Primary DI
- 04719873857661
- Version / Model
- KS-747.2
- Catalog Number
- 110404050037
- Company Name
- KARMA MEDICAL PRODUCTS CO., LTD.
- Labeler DUNS
- 656291275
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-25
- Public Version
- 1
- Public Version Date
- 2026-03-05
- Public Version Status
- New
- Public Device Record Key
- 42ced093-e827-46f2-bcff-644b15f9f08c
Device Description
Karma's KS-747.2 are classified as a Class B mobility product for indoor and outdoor use. This scooter is suitable for one single user up to 135 kg in weight. It also has an extremely durable aluminum alloy frame with tough accessories and does not suffer in dramatic extremes of temperature. The expected service life of the product is five years,
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | Physical Medicine | 890.3800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45684 | Assistive scooter, electric-motor-driven | A battery-powered, electric-motor-driven mobility device designed to be operated by a person with a disability and consisting of a seat over two rear wheels, a platform for the feet, and handlebars in front to turn one or two steerable front wheels connected via a steering-column. Commonly referred to as a mobility scooter, it is used to enhance the user's ability for self-transportation in the local environment and/or to promote the user's physical/recreational activities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04719873857661 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K041677 | 000 |