Amigo Mobility Intl., Inc.
6693 DIXIE HWY., BRIDGEPORT, MI, US
Registered product codes
3 product codes
Recent MDR events
2 on file
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 1821729.
FDA inspections
2 on file
- Official Action Indicated (OAI)Feb 5, 2026
Compliance: Devices · Citations posted
- Official Action Indicated (OAI)Feb 5, 2026
Postmarket Assurance: Devices · Citations posted
Inspection citations
6 on file
Top cited requirements
Compare to industry ↗ISO 13485:2016 Clause 6.2Process(es) for personnel competence, training and awareness not documented
1ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
1ISO 13485:2016 Clause 7.6Procedures for monitoring and measuring equipment requirements not documented
1ISO 13485:2016 Clause 8.2.4Objectivity and impartiality of internal audit process not ensured
1ISO 13485:2016 Clause 8.3.1Nonconforming product not adequately evaluated
1ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
1
- ISO 13485:2016 Clause 6.2Feb 5, 2026
Process(es) for personnel competence, training and awareness not documented
- ISO 13485:2016 Clause 7.1Feb 5, 2026
Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.6Feb 5, 2026
Procedures for monitoring and measuring equipment requirements not documented
- ISO 13485:2016 Clause 8.2.4Feb 5, 2026
Objectivity and impartiality of internal audit process not ensured
- ISO 13485:2016 Clause 8.3.1Feb 5, 2026
Nonconforming product not adequately evaluated
- ISO 13485:2016 Clause 8.5.2Feb 5, 2026
Corrective action procedures not documented
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.