Data / Medical devices / United States / Mettler Electronics Corp.

Mettler Electronics Corp.: FDA-registered device maker in Anaheim, CA, United States, 13 510(k) clearances

Name: Mettler Electronics Corp. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Mettler Electronics Corp. is registered with the FDA (registration 2013558) in Anaheim, CA, United States. It lists 15 device types. The FDA files 13 510(k) clearances under its listings, the newest dated March 21, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Mettler Electronics Corp.

FDA registration number: 2013558
Address: 1024 E Arlee Pl, Anaheim, CA, United States, 92805
Owner or operator: Mettler Electronics Corp. (9049525)
Roles: Manufacturer, Repackager or relabeler
First device listed: October 23, 1992
Registered through: 2026
Brand names listed: Auto*Therm 390, Auto*Wave 695, MTD 4000, Sonicator 740, Sonicator Plus 920, Sonicator Plus 940, Sys*Stim 208 and Sys*Stim 208A, Sys*Stim 211 and more

Devices it lists

Device	Product code	Class	Role	Source
Cleaner, Ultrasonic, Medical Instrument	FLG	1	Repackager or relabeler	accessdata.fda.gov
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat	IMJ	2	Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Repackager or relabeler	accessdata.fda.gov
Equipment, Traction, Powered	ITH	2	Repackager or relabeler	accessdata.fda.gov
Interferential Current Therapy	LIH	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Manufacturer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Transcutaneous, For Arthritis	NYN	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Neuromuscular, External Functional	GZI	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat	IMG	2	Repackager or relabeler	accessdata.fda.gov
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat	IMI	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 21, 2024	K233926	accufit	IPF	Substantially Equivalent	Mettler Electronics Corporation	accessdata.fda.gov
November 14, 2014	K141299	OTC COMBO TENS/EMS SYSTEM	NUH	Substantially Equivalent	Well-Life Healthcare Limited	accessdata.fda.gov
June 26, 2012	K113017	SYS*STIM 240	IPF	Substantially Equivalent	Mettler Electronics Corp.	accessdata.fda.gov
August 25, 2011	K111482	SONICATOR PLUS 920	IMG	Substantially Equivalent	Mettler Electronics Corp.	accessdata.fda.gov
October 8, 2009	K091540	MTD 4000	ITH	Substantially Equivalent	Mettler Electronics Corp.	accessdata.fda.gov
August 1, 2007	K071137	SONICATOR PLUS 940, MODEL ME940	IMG	Substantially Equivalent	Mettler Electronics Corp.	accessdata.fda.gov
May 4, 2006	K053546	SONICATOR 740, MODEL ME 740	IMI	Substantially Equivalent	Mettler Electronics Corp.	accessdata.fda.gov
October 8, 2004	K042554	AUTO THERM 390, MODEL ME 390	IMJ	Substantially Equivalent	Mettler Electronics Corp.	accessdata.fda.gov
December 10, 2003	K032720	GEM-STIM TENS, MODELS GM3XY AND GM3AXY	GZJ	Substantially Equivalent	Gemore Technology Co, Ltd.	accessdata.fda.gov
May 30, 2003	K031017	SYS*STIM 208 AND 208A	IPF	Substantially Equivalent	Mettler Electronics Corp.	accessdata.fda.gov
July 27, 2001	K002874	WELL-TENS	GZJ	Substantially Equivalent	Well-Life Consultant	accessdata.fda.gov
September 17, 1999	K983097	TENS/FES/NMES ELECTRODES	GXY	Substantially Equivalent	Uni-Patch, Inc.	accessdata.fda.gov
February 3, 1997	K964028	SYS STIM 226	IPF	Substantially Equivalent	Mettler Electronics Corp.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 14, 2011	58787	Not yet classified	Terminated	MTD 4000 - Mettler Traction Decompression System, Model: ME 4000 Product Usage: Provide traction and mobilization of skeletal structures and skeletal muscles	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.	accessdata.fda.gov

Compare with other makers

Updated March 21, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.