# K110350: Kneehab XP

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Medical Research, Ltd.
- Decided: Aug 3, 2011 after 177 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: 4 generations back to K010335 (2001). 17 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083105: Kneehab XP Conductive Garment, Type 411, Bio-Medical Research, Ltd. (2009) Summary page 1.
- K082011: Medistim XP, Type 281 and Meditens XP, Type 458, Bio-Medical Research, Ltd. (2008) Summary page 2.
- K061516: Staodyn Max Preset, Model 4470, Compex Technologies, Inc. (2007) Summary page 2.
- K021100: 300 PV Complete Electrotherapy System, Empi (2002) Summary page 5.
- K971437: Bionicare Stimulator System. Model Bio-1000, Murray Electronics (1997) Summary page 2.

## Most influential descendants
- K150413: QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator (2015), 7 descendants of its own
- K163067: CyMedica e-vive™ System; CY-1000 (2016), 4 descendants of its own
- K212832: TimeWaver Frequency (2021), 1 descendant of its own
- K210674: Shoulder Pacemaker (2021), 1 descendant of its own
- K210604: Intellihab System (2021), 1 descendant of its own

## Indications for use
The Kneehab XP, Type 412/421, Indications for use are as follows: In NMES mode (Programs 1-6) the Kneehab XP is intended to: * Maintain or increase the range of motion. * Prevention or retardation of disuse atrophy * Re-educate muscles Early post-surgical quadriceps strengthening and improved post surgical knee stability secondary to quadriceps strengthening * Relax muscle spasms * Increase blood circulation In TENS Mode (Programs 7 - 9) the Kneehab XP is intended to: * Provide symptomatic relief and management of chronic, intractable pain * Provide an adjunctive treatment in the management of acute, post-surgical or post-traumatic pain * Provide symptomatic relief and management of intractable pain and relief of pain associated with arthritis * Provide an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee

Source page: https://510kreport.com/device/K110350
Methodology: https://510kreport.com/methodology