Device Classification Name |
massager, therapeutic, electric
|
510(k) Number |
K210451 |
Device Name |
OrthoGold 100 |
Applicant |
Tissue Regeneration Technologies, LLC |
251 Heritage Walk |
Woodstock,
GA
30188
|
|
Applicant Contact |
John Warlick |
Correspondent |
M Squared Associates, INC |
127 West 30th St Floor 9 |
New York,
NY
10001
|
|
Correspondent Contact |
Cherita James |
Regulation Number | 890.5660
|
Classification Product Code |
|
Date Received | 02/16/2021 |
Decision Date | 05/05/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|