Identity
- Trade Name
- TM-400 FDA UDI
- Generic Name
- Intermittent powered traction system FDA UDI
- Device Name
- Traction Device FDA UDI
- Model / Reference
- TM-400 FDA UDI
- Description
- Traction Device FDA UDI
Identifiers
- Catalog Number
- TM-400 FDA UDI
- Primary DI / UDI-DI
- 04983087007932 FDA UDI
- 510(k) Number
- K081247 FDA UDI
- FDA Product Code
- ITH FDA UDI
- GMDN Term
- Intermittent powered traction system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intermittent powered traction system
Tm-400 by Ito Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intermittent powered traction system.
- Dynatron SmarTRAC — Dynatronics Corp. · Class II
- Discectomy Set — SPINEOLOGY INC. · Class I
- Discectomy Set — SPINEOLOGY INC. · Class I
- Dynatron TX900+ Traction System — Dynatronics Corp. · Class II
- Mettler — ZMI Electronics Ltd. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ito Co., Ltd.
Sources (1)
- FDA UDI 06066111-fe0b-46a4-9e8e-1fde8e106c25 35 fields · synced May 30, 2026