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TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx

FDA UDI

Class II (US FDA UDI)

by Invacare Corp.

Identity

Trade Name
TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx FDA UDI
Generic Name
Electric-motor-driven wheelchair, occupant-controlled FDA UDI
Model / Reference
TDXSP2-MCG FDA UDI

Identifiers

Primary DI / UDI-DI
00841447100966 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
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

Category: Electric-motor-driven wheelchair, occupant-controlled

TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx by Invacare Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electric-motor-driven wheelchair, occupant-controlled.

Cleared under the same submission

K170507 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Invacare Corp.

Sources (1)

  • FDA UDI f1275bbc-21a2-4572-8c44-81ef90ff4f51 35 fields · synced May 30, 2026