Aha Technologies, Inc.
18447 W 8 Mile Road, Detroit, MI, US
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 3026940243.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Oct 14, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Oct 14, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
10 on file
Top cited requirements
Compare to industry ↗21 CFR 801.20(a)Label to bear a unique device identifier
121 CFR 820.20(e)Quality System Procedures
121 CFR 820.30(a)Design control - no procedures
121 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
121 CFR 820.40Procedures not adequately established or maintained
121 CFR 820.50Purchasing controls, Lack of or inadequate procedures
1
- 21 CFR 801.20(a)Oct 14, 2025
Label to bear a unique device identifier
- 21 CFR 820.20(e)Oct 14, 2025
Quality System Procedures
- 21 CFR 820.30(a)Oct 14, 2025
Design control - no procedures
- 21 CFR 820.30(g)Oct 14, 2025
Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.40Oct 14, 2025
Procedures not adequately established or maintained
- 21 CFR 820.50Oct 14, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(a)Oct 14, 2025
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Oct 14, 2025
Lack of or inadequate procedures
- 21 CFR 820.198(a)Oct 14, 2025
Lack of or inadequate complaint procedures
- 21 CFR 830.300(a)Oct 14, 2025
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.