The following data is part of a premarket notification filed by Guangzhou Finecure Medical Equipment Co.,ltd with the FDA for Electrotherapy Device (combo Unit).
| Device ID | K130691 |
| 510k Number | K130691 |
| Device Name: | ELECTROTHERAPY DEVICE (COMBO UNIT) |
| Classification | Stimulator, Muscle, Powered |
| Applicant | GUANGZHOU FINECURE MEDICAL EQUIPMENT CO.,LTD 05C.FUHAI KANGLE BUILDING NASHAN DISTRICT Shenzhen, CN 518000 |
| Contact | Field Fu |
| Correspondent | Field Fu GUANGZHOU FINECURE MEDICAL EQUIPMENT CO.,LTD 05C.FUHAI KANGLE BUILDING NASHAN DISTRICT Shenzhen, CN 518000 |
| Product Code | IPF |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-13 |
| Decision Date | 2013-12-20 |