Tm-400
Tm-400 is a Class II device made by Ito Co., Ltd., cleared under FDA 510(k) K081247 on 25 Aug 2008 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 04983087007932), active as of 21 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04983087007932 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK081247 | Date25 Aug 2008 | StatusActive |
Official records
- AccessGUDID record 04983087007932
- FDA 510(k) database K081247
Across registries
- FDA 510(k) K081247 decided 25 Aug 2008 Active
- FDA GUDID UDI-DI 04983087007932 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K081247
- Listed FDA GUDID 04983087007932
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Intermittent powered traction system
- Model / Ref / Catalog
- TM-400
- Primary DI / UDI-DI
- 04983087007932
- 510(k) Number
- FDA product code
- ITH
- GMDN term
- Intermittent powered traction system
- Device class
- Class II
- Regulation number
- 890.5900
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code ITH (Equipment, Traction, Powered).
- ASH-7000 by U.S. Table, Inc.
- Traction 230 by Tri W-G, Inc.
- TABLE, TREATMENT & TRACTION, HI-LO by Will Ross Co.
- JILCO TRACTION-FLEXION CHAIR by Jilco Enterprises
- DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM by Axiom Worldwide, Inc.
- ESCOTEK EST TRAC 401 by Nor-Am Patient Care Products, Inc.
- True Non-Surgical Spinal Decompression System (DRX9000-SL) by Excite Medical of Tampa Bay, LLC
- DRX9000C-SL Cervical Spinal Decompression System by Excite Medical of Tampa Bay, LLC
- AMT THERAPEUTIC TABLE, MODEL 748AMT by Amt Mfg., Inc.
- ITRAC Cervical Traction System by Pivotal Health Solutions