FEI 1000306115
Ergomed, Inc.
5426 Billington Dr, SAN ANTONIO, TX, US
MDR events2All time
Recalls0All time
Registered products1
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
Registered product codes
1 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 1000306115.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Dec 6, 2023
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Dec 6, 2023
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 801.20(a)Dec 6, 2023
Label to bear a unique device identifier
- 21 CFR 820.198(a)Dec 6, 2023
Complaints
- 21 CFR 830.300(a)Dec 6, 2023
Devices subject to device identification GUDID data submission requirements.
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.