The following data is part of a premarket notification filed by Stimel Ltd with the FDA for Stimel-03.
| Device ID | K130424 |
| 510k Number | K130424 |
| Device Name: | STIMEL-03 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | STIMEL LTD 57 LAZY BROOK ROAD Monroe, CT 06468 |
| Contact | Raymond J Kelly Iv |
| Correspondent | Raymond J Kelly Iv STIMEL LTD 57 LAZY BROOK ROAD Monroe, CT 06468 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-20 |
| Decision Date | 2013-07-11 |