FEI 3010201075
Portable Therapeutix
9000 Southwest Fwy, Houston, TX, US
MDR events0All time
Recalls0All time
Registered products2
Establishment typeRepackRepack or Relabel Medical Device
Registered product codes
2 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 3010201075.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Nov 12, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Nov 12, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
5 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(i)Nov 12, 2024
Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.40Nov 12, 2024
Procedures not adequately established or maintained
- 21 CFR 820.80(d)Nov 12, 2024
Lack of or inadequate final acceptance procedures
- 21 CFR 820.100(a)Nov 12, 2024
Lack of or inadequate procedures
- 21 CFR 820.184Nov 12, 2024
DHR content
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.