The following data is part of a premarket notification filed by Johari Digital Healthcare, Ltd. with the FDA for Powertone, Model Pt-11.
| Device ID | K062439 |
| 510k Number | K062439 |
| Device Name: | POWERTONE, MODEL PT-11 |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | JOHARI DIGITAL HEALTHCARE, LTD. 26540 W. AGOURA ROAD SUITE 230 Calabases, CA 91302 |
| Contact | Nisha Johari |
| Correspondent | Nisha Johari JOHARI DIGITAL HEALTHCARE, LTD. 26540 W. AGOURA ROAD SUITE 230 Calabases, CA 91302 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-21 |
| Decision Date | 2007-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08908008085246 | K062439 | 000 |