The following data is part of a premarket notification filed by Advanced Back Technologies with the FDA for Extentrac Elite.
| Device ID | K031996 |
| 510k Number | K031996 |
| Device Name: | EXTENTRAC ELITE |
| Classification | Equipment, Traction, Powered |
| Applicant | ADVANCED BACK TECHNOLOGIES 227 JACKSON AVE. Syosset, NY 11791 |
| Contact | David F Cuccia |
| Correspondent | David F Cuccia ADVANCED BACK TECHNOLOGIES 227 JACKSON AVE. Syosset, NY 11791 |
| Product Code | ITH |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-27 |
| Decision Date | 2004-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B727M100 | K031996 | 000 |