Atlas FDA

MTD 4000

FDA 510(k) clearance K091540 · decided 2009-10-08

Clearance details

K-number
K091540
Device name
MTD 4000
Applicant
Mettler Electronics Corp.
Decision
Substantially Equivalent
Date received
2009-05-26
Decision date
2009-10-08
Days to decision
135 days
Clearance type
Abbreviated
Product code
ITH
Device class
2
Regulation number
890.5900
Medical specialty
Physical Medicine
Advisory committee
Physical Medicine
Location
Anaheim, CA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Mettler Electronics Corp.

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
True Non-Surgical Spinal Decompression System (DRX9000-SL) (K243775)Excite Medical of Tampa Bay, LLC2025-07-18
DRX9000C-SL Cervical Spinal Decompression System (K243366)Excite Medical of Tampa Bay, LLC2025-06-18
Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac (K214037)Ergo-Flex Technologies, LLC2024-02-22
c1Trac (K222912)Zimmer Medizinsysteme GmbH2023-05-16
ELTRAC 471 (K151640)Enraf-Nonius, B.V.2015-10-16
Modpod (K150695)Hollywog, LLC2015-08-13
ITRAC CERVICAL TRACTION SYSTEM (K131983)Pivotal Health Solutions2014-09-10
INTEGRITY SPINAL CARE SYSTEM 3.0 (K130249)Integrity Life Sciences2014-02-06
EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 (K112074)Everyway Medical Instruments Co.,Ltd2012-02-01
INTEGRITY SPINAL CARE SYSTEM (K103248)Integra Life Sciences2011-04-05
DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE (K101889)Pivotal Health Solutions2010-08-27
TM-400 (K081247)Ito Co., Ltd.2008-08-25

Recalls involving this device

RecordFirmDate
MTD 4000 - Mettler Traction Decompression System, Model: ME 4000 Product Usage: Provide tr recall (Z-2580-2011)Mettler Electronics Corp2011-06-17