# K984142: Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994, Model Number ME 994

- Pathway: 510(k) (Traditional)
- Applicant: Mettler Electronics Corp.
- Decided: Feb 9, 1999 after 83 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
34 later devices descend from it; 3 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K071137: Sonicator Plus 940, Model ME940 (2007), 19 descendants of its own
- K093138: MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and MT9003 (2010), 15 descendants of its own
- K013192: Sonicator Plus 930, Model ME 930 (2001), 11 descendants of its own
- K113010: FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens Stimulator (2012), 8 descendants of its own
- K181688: R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator (2018), 6 descendants of its own

## Indications for use
Therapeutic Ultrasound Pain relief Reduction of muscle spasm Localized increase in blood flow Increase range of motion of contracted joints using heat and stretch techniques. Neuromuscular Stimulation Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (Interferential, Premodulated and Microcurrent waveforms) Temporary relaxation of muscle spasm, (all waveforms except Microcurrent) Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles, (all waveforms except Microcurrent) Increase of blood flow in the treatment area, (all waveforms except Microcurrent) Prevention or retardation of disuse atrophy in post-injury type conditions, (all waveforms except Microcurrent) Muscle re-education, (all waveforms except Microcurrent) Maintaining or increasing range of motion, (all waveforms except Microcurrent)

Source page: https://510kreport.com/device/K984142
Methodology: https://510kreport.com/methodology