Device Classification Name |
electromagnetic stimulator, pain relief
|
510(k) Number |
K210021 |
Device Name |
Axon Therapy |
Applicant |
NeuraLace Medical, Inc. |
3770 Tansy St #101 |
San Diego,
CA
92121
|
|
Applicant Contact |
Joe Milkovits |
Correspondent |
AcKnowledge Regulatory Strategies LLC |
2251 San Diego Ave, Suite B-257 |
San Diego,
CA
92121
|
|
Correspondent Contact |
Allison C. Komiyama |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/04/2021 |
Decision Date | 06/11/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|