The following data is part of a premarket notification filed by Johari Digital Healthcare Limited with the FDA for Torc Body.
Device ID | K192039 |
510k Number | K192039 |
Device Name: | Torc Body |
Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
Applicant | Johari Digital Healthcare Limited G-582, 584 EPIP, Boranada Jodhpur, IN 342008 |
Contact | Pooja Johari |
Correspondent | Pooja Johari Johari Digital Healthcare Limited G-582, 584 EPIP, Boranada Jodhpur, IN 342008 |
Product Code | NGX |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-07-30 |
Decision Date | 2020-03-29 |