Identity
- Trade Name
- MERITS FDA UDI
- Generic Name
- Wheelchair, power-assisted, occupant-controlled, non-collapsible FDA UDI
- Model / Reference
- P326AAARMUB FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04714379292176 FDA UDI
- 510(k) Number
- K012802 FDA UDI
- FDA Product Code
- ITI FDA UDI
- GMDN Term
- Wheelchair, power-assisted, occupant-controlled, non-collapsible FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wheelchair, power-assisted, occupant-controlled, non-collapsible
Merits by Merits Health Products., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wheelchair, power-assisted, occupant-controlled, non-collapsible.
- MERITS — MERITS HEALTH PRODUCTS., INC. · Class II
- MERITS — MERITS HEALTH PRODUCTS., INC. · Class II
- MERITS — MERITS HEALTH PRODUCTS., INC. · Class II
- MERITS — MERITS HEALTH PRODUCTS., INC. · Class II
- MERITS — MERITS HEALTH PRODUCTS., INC. · Class II
- MERITS — MERITS HEALTH PRODUCTS., INC. · Class II
- MERITS — MERITS HEALTH PRODUCTS., INC. · Class II
- MERITS — MERITS HEALTH PRODUCTS., INC. · Class II
Cleared under the same submission
K012802 also covers:
- MERITS — MERITS HEALTH PRODUCTS., INC.
- MERITS — MERITS HEALTH PRODUCTS., INC.
- MERITS — MERITS HEALTH PRODUCTS., INC.
- MERITS — MERITS HEALTH PRODUCTS., INC.
- MERITS — MERITS HEALTH PRODUCTS., INC.
- MERITS — MERITS HEALTH PRODUCTS., INC.
- MERITS — MERITS HEALTH PRODUCTS., INC.
- MERITS — MERITS HEALTH PRODUCTS., INC.
- MERITS — MERITS HEALTH PRODUCTS., INC.
- MERITS — MERITS HEALTH PRODUCTS., INC.
- MERITS — MERITS HEALTH PRODUCTS., INC.
- MERITS — MERITS HEALTH PRODUCTS., INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Merits Health Products., Inc.
Sources (1)
- FDA UDI cbee033b-5c3e-4842-b8a3-f324566bf986 33 fields · synced Jun 1, 2026