The following data is part of a premarket notification filed by Spr Therapeutics, Llc with the FDA for Smartpatch Pns Microlead And Accessories, Smartpatch Pns Stimulator, Pads, And Accessories, Smartpatch Pns Microlead And Introducer, Smartpatch Pns Pads, 4 Packs.
| Device ID | K161154 |
| 510k Number | K161154 |
| Device Name: | Smartpatch PNS MicroLead And Accessories, Smartpatch PNS Stimulator, Pads, And Accessories, Smartpatch PNS MicroLead And Introducer, Smartpatch PNS Pads, 4 Packs |
| Classification | Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief |
| Applicant | SPR THERAPEUTICS, LLC 22901 MILLCREEK BLVD., SUITE 110 Cleveland, OH 44122 |
| Contact | Kathryn Stager |
| Correspondent | Susan Alpert SFA CONSULTING, LLC 200 PARK AVENUE, UNIT 111 Minneapolis, MN 55415 |
| Product Code | NHI |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-25 |
| Decision Date | 2016-07-23 |
| Summary: | summary |