The following data is part of a premarket notification filed by Inmode Md Ltd. with the FDA for Embody System.
| Device ID | K183450 |
| 510k Number | K183450 |
| Device Name: | EmBody System |
| Classification | Massager, Therapeutic, Electric |
| Applicant | InMode MD Ltd. Tabor Building, Shaar Yokneam Yoqneam Illit, IL 2069200 |
| Contact | Amit Goren |
| Correspondent | Amit Goren A. Stein – Regulatory Affairs Consulting Ltd. 20 Hata’as Str., Suite 102 Kfar Saba, IL 4442520 |
| Product Code | ISA |
| Subsequent Product Code | NUV |
| Subsequent Product Code | PBX |
| CFR Regulation Number | 890.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-12 |
| Decision Date | 2019-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016633528 | K183450 | 000 |
| 07290016633511 | K183450 | 000 |