Mettler Electronics Corp
Anaheim, CA, US
METTLER ELECTRONICS CORP. appears in FDA device records in Anaheim, CA. FDA records list 34 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 34 510(k) clearances for Mettler Electronics Corp between 1985 and 2024. The busiest year on record is 1985, with 4. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 4 |
| 1986 | 2 |
| 1987 | 1 |
| 1988 | 3 |
| 1989 | 3 |
| 1993 | 1 |
| 1994 | 3 |
| 1995 | 1 |
| 1997 | 1 |
| 1999 | 2 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233926 | accufit | IPF | Substantially Equivalent | |
| K223802 | accufit | IPF | Substantially Equivalent | |
| K113017 | SYS*STIM 240 | IPF | Substantially Equivalent | |
| K111482 | SONICATOR PLUS 920 | IMG | Substantially Equivalent | |
| K091540 | MTD 4000 | ITH | Substantially Equivalent | |
| K071137 | SONICATOR PLUS 940, MODEL ME940 | IMG | Substantially Equivalent | |
| K053546 | SONICATOR 740, MODEL ME 740 | IMI | Substantially Equivalent | |
| K043586 | LASER SYS*STIM 540, MODEL ME 540 | ILY | Substantially Equivalent | |
| K042554 | AUTO THERM 390, MODEL ME 390 | IMJ | Substantially Equivalent | |
| K031017 | SYS*STIM 208 AND 208A | IPF | Substantially Equivalent | |
| K023083 | SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800 | FRN | Substantially Equivalent - Subject to Tracking Reg. | |
| K022458 | AUTO*THERM 395, MODEL ME 395 | IMJ | Substantially Equivalent | |
| K013192 | SONICATOR PLUS 930, MODEL ME 930 | IMI | Substantially Equivalent | |
| K984142 | SONICATOR PLUS 992, MODEL NUMBER ME 992 AND SONICATOR PLUS 994, MODEL NUMBER ME 994 | IPF | Substantially Equivalent | |
| K984114 | SYS STIM 294, MODEL ME 294 | IPF | Substantially Equivalent | |
| K964028 | SYS STIM 226 | IPF | Substantially Equivalent | |
| K951916 | CC RIDER, MODEL ME180 | IKK | Substantially Equivalent | |
| K943469 | SONICATOR 730 | IMG | Substantially Equivalent | |
| K934846 | SONICATOR 716 | IMG | Substantially Equivalent | |
| K934845 | SONICATOR 715 | IMG | Substantially Equivalent | |
| K921436 | SONICATOR PLUS | IMG | Substantially Equivalent | |
| K893879 | SYS*STIM 207A | IPF | Substantially Equivalent | |
| K893878 | SYS*STIM 206A | IPF | Substantially Equivalent | |
| K883080 | SYS*STIM 220 | LIH | Substantially Equivalent | |
| K883228 | SONICATOR 720 (MODEL ME720) | IMI | Substantially Equivalent | |
| K880901 | SONICATOR 710 (MODEL ME710) | IMI | Substantially Equivalent | |
| K880602 | MODIFIED SONICATOR 720, MODEL ME720 | IMI | Substantially Equivalent | |
| K873812 | SONICATOR 720 (MODEL ME720) | IMI | Substantially Equivalent | |
| K860107 | SYS*STIM 206 (MODEL-ME 206) | IPF | Substantially Equivalent for Some Indications | |
| K855249 | MIDIFICATION SYS*STIM 207 (MODEL-ME207) | IPF | Substantially Equivalent for Some Indications | |
| K853750 | SYS*STIM 207 MODEL ME 207 | IPF | Substantially Equivalent for Some Indications | |
| K851735 | SYS STIM 206 MODEL ME206 | GZJ | Substantially Equivalent | |
| K851397 | SONICATOR 705 MODEL ME 705 | IMI | Substantially Equivalent | |
| K850013 | SYS STIM 206(MODEL-ME 206) MUSCLE STIMULATOR | IPF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2013558 | 2013558 | METTLER ELECTRONICS CORP. | 1024 E Arlee Pl, ANAHEIM, CA 92805 US | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FLGCleaner, Ultrasonic, Medical Instrument
- IMJDiathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
- GXYElectrode, Cutaneous
- ITHEquipment, Traction, Powered
- LIHInterferential Current Therapy
- ILYLamp, Infrared, Therapeutic Heating
- ISAMassager, Therapeutic, Electric
- FRNPump, Infusion
- NYNStimulator, Electrical, Transcutaneous, For Arthritis
- IPFStimulator, Muscle, Powered
- NGXStimulator, Muscle, Powered, For Muscle Conditioning
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
- GZIStimulator, Neuromuscular, External Functional
- IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
- IKKSystem, Isokinetic Testing And Evaluation
- IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2580-2011 | 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. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain
