The following data is part of a premarket notification filed by Reliefband Technologies with the FDA for Reliefband 1.5.
Device ID | K173233 |
510k Number | K173233 |
Device Name: | ReliefBand 1.5 |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | ReliefBand Technologies 220 Gibraltar Rd Ste 270 Horsham, PA 19044 |
Contact | Dave Hartman |
Correspondent | Barbara Whitman Whitman Regulatory Consulting 616 Revere Court Flemington, NJ 08822 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-10-05 |
Decision Date | 2017-11-30 |
Summary: | summary |