Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3039318471

FEI Number

3039318471

Entity Name

SMARTE CARTE, INC. DBA SMARTE CARTE MOBILITY

City/State/Country

Charlotte, NC, US

Establishment Address

3101 Yorkmont Rd Ste 1600, Charlotte, NC 28208, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Smarte Carte, Inc. dba Smarte Carte Mobility (Owner Number: 10095665)

Owner / Operator Contact Address

3101 Yorkmont Road, Suite 1600, Charlotte, NC 28208, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2026-04-17
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2026-04-10

Official Correspondent

Justin Mauldin

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Smarte Carte, Inc. dba Smarte Carte Mobility

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2018	Handicare Usa Inc	1	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Z-0014-2018	Handicare AB Maskinvagen	1	Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3039318471. Last updated year: 2026. Please use registration number 3039318471 when referencing this establishment in official correspondence.