The following data is part of a premarket notification filed by Pt Products, Llc with the FDA for Cycletrac Ct-5000.
| Device ID | K073542 |
| 510k Number | K073542 |
| Device Name: | CYCLETRAC CT-5000 |
| Classification | Equipment, Traction, Powered |
| Applicant | PT PRODUCTS, LLC 24543 INDOPLEX CIRCLE Farmington Hills, MI 48335 |
| Contact | Michele Conway |
| Correspondent | Michele Conway PT PRODUCTS, LLC 24543 INDOPLEX CIRCLE Farmington Hills, MI 48335 |
| Product Code | ITH |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-17 |
| Decision Date | 2008-02-14 |
| Summary: | summary |