The following data is part of a premarket notification filed by Anhui Jinjianqiao Med-tech Co,. Ltd. with the FDA for Tcm Massager.
| Device ID | K130150 |
| 510k Number | K130150 |
| Device Name: | TCM MASSAGER |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | ANHUI JINJIANQIAO MED-TECH CO,. LTD. 05C.FUHAI KANGLE BUILDING NANSHAN DISTRICT SHENZHEN Shenzhen, Guangdong, CN 518000 |
| Contact | Field Fu |
| Correspondent | Field Fu ANHUI JINJIANQIAO MED-TECH CO,. LTD. 05C.FUHAI KANGLE BUILDING NANSHAN DISTRICT SHENZHEN Shenzhen, Guangdong, CN 518000 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-22 |
| Decision Date | 2013-09-26 |