The following data is part of a premarket notification filed by Mid-america Medical Innovations Llc with the FDA for Cp Relief Wand-otc.
| Device ID | K162630 |
| 510k Number | K162630 |
| Device Name: | CP Relief Wand-OTC |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Mid-America Medical Innovations LLC 2704 Industrial Drive Jefferson City, MO 65109 |
| Contact | Norm Schroeder |
| Correspondent | Norm Schroeder Mid-America Medical Innovations LLC 2704 Industrial Drive Jefferson City, MO 65109 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-21 |
| Decision Date | 2016-12-20 |