The following data is part of a premarket notification filed by Btl with the FDA for Btl-703-2.
| Device ID | K200382 |
| 510k Number | K200382 |
| Device Name: | BTL-703-2 |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | BTL 362 Elm Street Marlborough, MA 01752 |
| Contact | David Chmel |
| Correspondent | David Chmel BTL 362 Elm Street Marlborough, MA 01752 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-18 |
| Decision Date | 2021-01-06 |