# K070888: Combi 8 Max

- Pathway: 510(k) (Abbreviated)
- Applicant: Cec Electronica S.R.L.
- Decided: Jul 3, 2008 after 461 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
Longest line of descent: 2 generations back to K945509 (1995). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984114: Sys Stim 294, Model ME 294, Mettler Electronics Corp. (1999) Summary page 1.
- K062354: Vectra Genisys VMS FR, Encore Medical L.P. (2007) Summary page 1.
- K960969: Galva 5-T, Zimmer Elektromedizin GmbH (1996) Summary page 1.

## Most influential descendants
- K123642: Muscle Stimulation System (2013), 1 descendant of its own
- K150742: Muscle Stimulation System 110 (2015), 0 descendants of its own

## Indications for use
Depending on device model, and the specific waveform applied - COMBI pulse generators are indicated for the following uses: COMBI 4/8 DIGITAL, COMBI TREND 4/8 * Relaxation of muscle spasms · Prevention or retardation of disuse atrophy · Increasing local blood circulation * Muscle re-education · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis * Maintaining or increasing range of motion. COMBI 4/8 MAX * Relaxation of muscle spasms · Prevention or retardation of disuse atrophy · Increasing local blood circulation · Muscle re-education · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis · Maintaining or increasing range of motion. For TENS waveform: · Relief of chronic, intractable pain · Adjunctive treatment of post surgical or post traumatic acute pain

Source page: https://510kreport.com/device/K070888
Methodology: https://510kreport.com/methodology