The following data is part of a premarket notification filed by Fook Tin Technologies Limited with the FDA for Scaleman Body Fat Scales, Model: Fs-148bw1 Series.
| Device ID | K083838 |
| 510k Number | K083838 |
| Device Name: | SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES |
| Classification | Analyzer, Body Composition |
| Applicant | FOOK TIN TECHNOLOGIES LIMITED 4/F., EASTERN CENTRE 1065 KING'S ROAD Quarry Bay, HK |
| Contact | John Chai |
| Correspondent | John Chai FOOK TIN TECHNOLOGIES LIMITED 4/F., EASTERN CENTRE 1065 KING'S ROAD Quarry Bay, HK |
| Product Code | MNW |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-23 |
| Decision Date | 2009-05-12 |
| Summary: | summary |