The following data is part of a premarket notification filed by Ampcare, Llc with the FDA for Ampcare Esp Therapy System.
| Device ID | K131222 |
| 510k Number | K131222 |
| Device Name: | AMPCARE ESP THERAPY SYSTEM |
| Classification | Stimulator, Muscle, Powered |
| Applicant | AMPCARE, LLC 1201 RICHARDSON DRIVE SUITE 280 Richardson, TX 75080 |
| Contact | Diane Rutherford |
| Correspondent | Diane Rutherford AMPCARE, LLC 1201 RICHARDSON DRIVE SUITE 280 Richardson, TX 75080 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-30 |
| Decision Date | 2013-10-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06942808231016 | K131222 | 000 |