The following data is part of a premarket notification filed by Tissue Regeneration Technologies with the FDA for Orthogold 100.
| Device ID | K182682 |
| 510k Number | K182682 |
| Device Name: | OrthoGold 100 |
| Classification | Massager, Therapeutic, Electric |
| Applicant | Tissue Regeneration Technologies 251 Heritage Walk Woodstock, GA 30188 |
| Contact | John Warlick |
| Correspondent | Jennifer A. Daudelin M Squared Associates, Inc. 575 Eighth Avenue, Suite 1212 New York, NY 10018 |
| Product Code | ISA |
| CFR Regulation Number | 890.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-26 |
| Decision Date | 2018-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260484571618 | K182682 | 000 |