The following data is part of a premarket notification filed by Led Intellectual Properties, Llc with the FDA for Lightstim For Pain Led Belt.
Device ID | K151333 |
510k Number | K151333 |
Device Name: | LightStim For Pain LED Belt |
Classification | Lamp, Infrared, Therapeutic Heating |
Applicant | LED INTELLECTUAL PROPERTIES, LLC 16552 VON KARMAN AVE. Irvine, CA 92606 |
Contact | Steve Marchese |
Correspondent | Steve Marchese LED INTELLECTUAL PROPERTIES, LLC 16552 VON KARMAN AVE. Irvine, CA 92606 |
Product Code | ILY |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-05-19 |
Decision Date | 2015-08-21 |