Mettler ME4000
Mettler ME4000 (MTD4000) is an intermittent powered traction system (FDA Class II; FDA product code ITH, Equipment, Traction, Powered) made by ZMI Electronics Ltd., cleared under FDA 510(k) K091540 on 8 Oct 2009 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04719872330035), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04719872330035 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK091540 | Date8 Oct 2009 | StatusActive |
Official records
- AccessGUDID record 04719872330035
- FDA 510(k) database K091540
Across registries
- FDA 510(k) K091540 decided 8 Oct 2009 Active
- FDA GUDID UDI-DI 04719872330035 listed 23 Sep 2016 Listed
Recalls
-
- Terminated Z-2580-2011
The recall was initiated because Mettler has confirmed the possible failure of internal mechanical component and software detection for potential failure regarding Electronics Traction Device - MTD4000. The firm are initiating the recall because component failure might result in patient injury. Use of the device should cease immediately.
Timeline
- Cleared FDA 510(k) K091540
- Recall initiated FDA recalls Z-2580-2011
- Listed FDA GUDID 04719872330035
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mettler
- Generic name
- Intermittent powered traction system
- Model / Ref / Catalog
- ME4000, MTD4000
- Primary DI / UDI-DI
- 04719872330035
- 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).
- TM-400 by ITO CO., LTD.
- ATT-300 by Health Care Mfg., Inc.
- TRACTION SYSTEM, DIGIT-TRAC 930 by Ever Prosperous Instrument, Inc.
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- Decompression of Choice and Neuro Decompression Device by Pivotal Health Solutions
- CTBOX CERVICAL/LUMBAR TRACTION by Circular Traction Supply, Inc.
- VAX-D Genesis G2 System by Vax-D Medical Technologies, LLC
- DRX 2000 Powered Traction Equipment by Axiom Worldwide, Inc.
- DISTRAC(TM) TABLE by Lossing Orthopedic, Inc.
- Ergo-Flex Technologies Back on Trac BOTGEN1 and Cervi-Trac by ERGO FLEX Technologies LLC