The following data is part of a premarket notification filed by Reliefband Technologies Llc with the FDA for Reliefband.
| Device ID | K191547 |
| 510k Number | K191547 |
| Device Name: | ReliefBand |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | ReliefBand Technologies LLC 220 Gibraltar Rd Ste 270 Horsham, PA 19044 |
| Contact | Barbara Whitman |
| Correspondent | Barbara Whitman ReliefBand Technologies LLC 220 Gibraltar Rd Ste 270 Horsham, PA 19044 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-12 |
| Decision Date | 2019-08-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10661168000188 | K191547 | 000 |
| 00661168000174 | K191547 | 000 |
| 10661168000164 | K191547 | 000 |
| 30661168800027 | K191547 | 000 |
| 30661168800010 | K191547 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() RELIEFBAND 88161362 not registered Dead/Abandoned |
ReliefBand Technologies, LLC 2018-10-19 |
![]() RELIEFBAND 78645971 3260073 Live/Registered |
ReliefBand Technologies LLC 2005-06-08 |