FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Stellar LEAP Manual Tilt Wheelchair
DI: B829221
·
Model: STELLAR LEAP
·
PDG Product Design Group Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Stellar LEAP Manual Tilt Wheelchair
- Primary DI
- B829221
- Version / Model
- STELLAR LEAP
- Catalog Number
- 5522
- Company Name
- PDG Product Design Group Inc
- Labeler DUNS
- 253873905
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-28
- Public Version
- 2
- Public Version Date
- 2025-11-25
- Public Version Status
- Update
- Public Device Record Key
- f9dd8453-c920-433b-a1b1-07924c1e8fb1
- Distribution End Date
- 2024-10-31
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| IOR | Wheelchair, Mechanical | Physical Medicine | 890.3850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41512 | Push-rim manual wheelchair, non-bariatric | A non-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize by pushing specially designed rims on the wheels while seated. It is designed with a pair of larger wheels with push-rims attached whereby the occupant propels the device by rotating both wheels; it typically includes rear-fitted handles designed for optional pushing by an attendant. It provides no function outside of wheeled mobilization. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B829221 | HIBCC |
Customer Contacts
- Phone
- 888-858-4422
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163432 | 000 |