The following data is part of a premarket notification filed by Besmed Health Business Corp. with the FDA for Besmed Various Models Of Powered Muscle Stimulator, Be-560/be-580.
| Device ID | K031375 |
| 510k Number | K031375 |
| Device Name: | BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | BESMED HEALTH BUSINESS CORP. 58 FU-CHIUN ST. Hsin Chu City, TW 300 |
| Contact | Dr. Jen Ke Min |
| Correspondent | Dr. Jen Ke Min BESMED HEALTH BUSINESS CORP. 58 FU-CHIUN ST. Hsin Chu City, TW 300 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-30 |
| Decision Date | 2003-11-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04716770925806 | K031375 | 000 |
| 04716770925608 | K031375 | 000 |
| 04716770005805 | K031375 | 000 |
| 04716770005607 | K031375 | 000 |