Tm-300 Traction System
510(k) K992545
Tm-300 Traction System is a Class II device made by Ito Co., Ltd., cleared under FDA 510(k) K992545 on 1 Sep 1999, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992545 | Date1 Sep 1999 | StatusActive |
Official records
- FDA 510(k) database K992545
Recalls
-
- Terminated Z-1444-05
The traction device may malfunction, producing oscillation and a jerking motion.
Timeline
- Cleared FDA 510(k) K992545
- Recall initiated FDA recalls Z-1444-05
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ITH
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5900
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code ITH (Equipment, Traction, Powered).
- HANG UPS POWER II by Stl Intl., Inc.
- ELTRAC 471 by Enraf-Nonius B.V.
- TRITON/TRU-TRAC/TX/TRITON DTS TRACTION by Chattanooga Group, Inc.
- INTEGRITY SPINAL CARE SYSTEM 3.0 by Integrity Life Sciences
- TEC TRACTION MACHINE by Akron Medical Corp.
- VAX-D THERAPEUTIC TABLE by Vat-Tech, Inc.
- SPINA SYSTEM by North American Medical Corp (Nam)
- ULTRA-TRAC by Practical Healthcare Devices, Inc.
- EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 by EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
- INTEGRITY SPINAL CARE SYSTEM by Integra Lifesciences Corp.