FEI 3011278898
Advanced Tactile Imaging, Inc.
1457 Lower Ferry Rd, Trenton, NJ, US
MDR events0All time
Recalls0All time
Registered products3
Establishment typeManufactureManufacture Medical Device
Registered product codes
3 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3011278898.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Dec 6, 2024
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Dec 6, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 803.17Dec 6, 2024
Lack of Written MDR Procedures
- 21 CFR 820.30(e)Dec 6, 2024
Design review - Lack of or inadequate procedures
- 21 CFR 820.30(f)Dec 6, 2024
Design verification - Lack of or inadequate procedures
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.