FDA UDI
In Commercial Distribution
🇺🇸 United States
Motion composites
DI: 00811774000062
·
Model: Helio A6
·
Motion Composites Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Motion composites
- Primary DI
- 00811774000062
- Version / Model
- Helio A6
- Company Name
- Motion Composites Inc
- Labeler DUNS
- 243913550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-24
- Public Version
- 1
- Public Version Date
- 2022-10-03
- Public Version Status
- New
- Public Device Record Key
- 532d189e-a0d7-4d6d-a536-8f444fc32eca
Device Description
Wheelchair mechanical
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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| IOR | Wheelchair, Mechanical | Physical Medicine | 890.3850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41622 | Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible | A wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be manually propelled by the user while seated in the device or by an attendant. The occupant moves the device by rotating both rear wheels. An attendant moves the device by pushing or pulling handles on the device. The device may be disassembled or folded for transport. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811774000062 | GS1 |
Customer Contacts
- Phone
- 1-866-650-6555
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143101 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile handle with care