The following data is part of a premarket notification filed by Johari Digital Healthcare, Ltd. with the FDA for Torc Body.
| Device ID | K131291 |
| 510k Number | K131291 |
| Device Name: | TORC BODY |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | JOHARI DIGITAL HEALTHCARE, LTD. 5703 OBERLIN DR. SUITE 306 San Diego, CA 92121 |
| Contact | Pooja Johari |
| Correspondent | Pooja Johari JOHARI DIGITAL HEALTHCARE, LTD. 5703 OBERLIN DR. SUITE 306 San Diego, CA 92121 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-06 |
| Decision Date | 2013-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08908008085345 | K131291 | 000 |
| 08908008085352 | K131291 | 000 |
| 08908008085093 | K131291 | 000 |