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 |