The following data is part of a premarket notification filed by Jintronix Inc. with the FDA for Jintronix Rehabilitation System (jrs).
| Device ID | K130847 |
| 510k Number | K130847 |
| Device Name: | JINTRONIX REHABILITATION SYSTEM (JRS) |
| Classification | Interactive Rehabilitation Exercise Devices |
| Applicant | JINTRONIX INC. 336 BRONTE ST SOUTH SUITE 224-225 Milton, Ontario, CA L9t 7w6 |
| Contact | Navneet Sekhon |
| Correspondent | Navneet Sekhon JINTRONIX INC. 336 BRONTE ST SOUTH SUITE 224-225 Milton, Ontario, CA L9t 7w6 |
| Product Code | LXJ |
| CFR Regulation Number | 890.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-26 |
| Decision Date | 2014-02-28 |
| Summary: | summary |