The following data is part of a premarket notification filed by Chirotronics, Inc. with the FDA for Jt-1 Powered Traction Unit.
Device ID | K923103 |
510k Number | K923103 |
Device Name: | JT-1 POWERED TRACTION UNIT |
Classification | Equipment, Traction, Powered |
Applicant | CHIROTRONICS, INC. 60 ROCK HILL RD. Asheville, NC 28803 |
Contact | Jeff W Smith |
Correspondent | Jeff W Smith CHIROTRONICS, INC. 60 ROCK HILL RD. Asheville, NC 28803 |
Product Code | ITH |
CFR Regulation Number | 890.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-25 |
Decision Date | 1992-11-09 |