Identity
- Trade Name
- TDX SP2 with LiNX Electronics FDA UDI
- Generic Name
- Electric-motor-driven wheelchair, occupant-controlled FDA UDI
- Model / Reference
- TDXSP2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841447100911 FDA UDI
- 510(k) Number
- K170507 FDA UDI
- FDA Product Code
- ITI FDA UDI
- GMDN Term
- Electric-motor-driven wheelchair, occupant-controlled FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3860 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
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
TDX SP2 with LiNX Electronics by Invacare Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K170507 also covers:
- Invacare® TDX SP2 with Captain's Seat — Invacare Corp.
- TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx — Invacare Corp.
- TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx — Invacare Corp.
- TDX SP2 Base for Single Act. System w/ Ultra Low Maxx — Invacare Corp.
- TDX SP2 Base for Single Act. System w/Ultra Low Maxx — Invacare Corp.
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
- Invacare Corp.
Sources (1)
- FDA UDI bb127da0-c3e2-4ff2-9b35-fc6c1dcc746b 36 fields · synced Jun 8, 2026