The following data is part of a premarket notification filed by Easymed Instruments Co., Ltd. with the FDA for Intrelief.
| Device ID | K211263 |
| 510k Number | K211263 |
| Device Name: | Intrelief |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | EasyMed Instruments Co., Ltd. 3F, 5F-6F, Blk A, Gupo Gongmao Bld, Fengxin Rd, Fengxiang Industrial District, Daliang, Shunde Foshan, CN 528300 |
| Contact | Jeffery (tingjie Wu) Wu |
| Correspondent | Jeffery (tingjie Wu) Wu EasyMed Instruments Co., Ltd. 3F, 5F-6F, Blk A, Gupo Gongmao Bld, Fengxin Rd, Fengxiang Industrial District, Daliang, Shunde Foshan, CN 528300 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-26 |
| Decision Date | 2021-12-30 |