Electromedical Technologies, Inc
16413 N. 91st Street, Scottsdale, AZ, US
Registered product codes
1 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 3006791967.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Apr 15, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Apr 15, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
8 on file
Top cited requirements
Compare to industry ↗21 CFR 820.22Quality Audit/Reaudit - conducted
121 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
121 CFR 820.50Purchasing controls, Lack of or inadequate procedures
121 CFR 820.100(a)Lack of or inadequate procedures
121 CFR 820.181DMR - not or inadequately maintained
121 CFR 820.184Lack of or inadequate DHR procedures
1
- 21 CFR 820.22Apr 15, 2025
Quality Audit/Reaudit - conducted
- 21 CFR 820.30(i)Apr 15, 2025
Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50Apr 15, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.100(a)Apr 15, 2025
Lack of or inadequate procedures
- 21 CFR 820.181Apr 15, 2025
DMR - not or inadequately maintained
- 21 CFR 820.184Apr 15, 2025
Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Apr 15, 2025
Lack of or inadequate complaint procedures
- 21 CFR 830.300(a)Apr 15, 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.