The following data is part of a premarket notification filed by Normatec Industries, Lp with the FDA for Pulse 2.0, Pulse Pro 2.0.
| Device ID | K183169 |
| 510k Number | K183169 |
| Device Name: | Pulse 2.0, Pulse Pro 2.0 |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | NormaTec Industries, LP 480 Pleasant St, Suite A200 Watertown, MA 02472 |
| Contact | Albert G. Sanford |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-11-16 |
| Decision Date | 2018-12-27 |
| Summary: | summary |