The following data is part of a premarket notification filed by Tissue Regeneration Technologies, Llc with the FDA for Orthogold 100.
| Device ID | K210451 |
| 510k Number | K210451 |
| Device Name: | OrthoGold 100 |
| Classification | Massager, Therapeutic, Electric |
| Applicant | Tissue Regeneration Technologies, LLC 251 Heritage Walk Woodstock, GA 30188 |
| Contact | John Warlick |
| Correspondent | Cherita James M Squared Associates, INC 127 West 30th St Floor 9 New York, NY 10001 |
| Product Code | ISA |
| CFR Regulation Number | 890.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-16 |
| Decision Date | 2021-05-05 |