# K081141: Combocare 2000

- Pathway: 510(k) (Traditional)
- Applicant: Xanacare Technologies, LLC
- Decided: Aug 29, 2008 after 129 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K001179 (2000). 16 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071445: Terraquant MQ2000 V.5 with the TQ-1TENS, Escada International, Inc. (2007) Summary page 2.
- K021755: Apex Medical Digital Tens TS1211, TS1212, Apex Medical Corp. (2002) Summary page 2.
- K061650: Select Tens, Model 4600S, Empi (2007) Summary page 2.
- K041530: Excalibur Light Therapy System, Model Sgiex-04-001, Stargate International, Inc. (2004) Summary page 2.
- K041565: Lazrpulsr 4X, Led Healing Light, LLC (2005) Summary page 2.
- K050668: GRT Lite, Model 8-a, Grt Solutions, Inc. (2006) Summary page 2.

## Most influential descendants
- K083202: Combocare 2000 (2008), 2 descendants of its own
- K083822: Laser Touchone (2009), 1 descendant of its own
- K160246: SimulCare II (TM) (2016), 0 descendants of its own
- K142025: Neurolumen PN-1000 (2015), 0 descendants of its own
- K102278: Quadra Bloc Tens Plus (2011), 0 descendants of its own

## Indications for use
The ComboCare 2000 is intended for the temporary relief of minor muscle and joint pain, promoting relaxation of muscle tissue, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic acute pain.

Source page: https://510kreport.com/device/K081141
Methodology: https://510kreport.com/methodology