The following data is part of a premarket notification filed by Ever Prosperous Instrument, Inc. with the FDA for Traction System, Digit-trac 930.
| Device ID | K052453 |
| 510k Number | K052453 |
| Device Name: | TRACTION SYSTEM, DIGIT-TRAC 930 |
| Classification | Equipment, Traction, Powered |
| Applicant | EVER PROSPEROUS INSTRUMENT, INC. NO. 58, FU-CHIUN STREET Hsin Chu City, TW 30067 |
| Contact | Ke-men Jen |
| Correspondent | Ke-men Jen EVER PROSPEROUS INSTRUMENT, INC. NO. 58, FU-CHIUN STREET Hsin Chu City, TW 30067 |
| Product Code | ITH |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-07 |
| Decision Date | 2006-01-13 |
| Summary: | summary |