# K082011: Medistim XP, Type 281 and Meditens XP, Type 458

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Medical Research, Ltd.
- Decided: Nov 28, 2008 after 136 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: 1 generation back to K014020 (2002). 2 ancestors in all.
14 later devices descend from it; 4 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014020: NT Meditens Plus, Type 290, Bio-Medical Research, Ltd. (2002) Summary page 1.
- K014019: Neurotech Medistim Plus, Type 291, Bio-Medical Research, Ltd. (2002) Summary page 1.

## Most influential descendants
- K110350: Kneehab XP (2011), 9 descendants of its own
- 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
- K193275: Nerve and Muscle Stimulator (2020), 2 descendants of its own
- K212832: TimeWaver Frequency (2021), 1 descendant of its own

## Indications for use
The symptomatic relief and management of chronic intractable pain. It is also an adjunctive treatment in the management of post-surgical and post-traumatic pain. The device has no curative value and should only be used in conjunction with medical supervision. Neuromuscular Electrical Stimulation (NMES) for 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 and maintaining or increasing range of motion. Transcutaneous Electrical Nerve Stimulation (TENS) for an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems.

Source page: https://510kreport.com/device/K082011
Methodology: https://510kreport.com/methodology