# K112258: Neurotech Plus

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Medical Research, Ltd.
- Decided: Jan 9, 2012 after 157 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: 2 generations back to K032003 (2004). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082011: Medistim XP, Type 281 and Meditens XP, Type 458, Bio-Medical Research, Ltd. (2008) Summary page 1.
- K061516: Staodyn Max Preset, Model 4470, Compex Technologies, Inc. (2007) Summary page 2.
- K971437: Bionicare Stimulator System. Model Bio-1000, Murray Electronics (1997)

## Indications for use
The Neurotech Plus device is indicated for the following: In combination Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS) modes, models 431, 432, 433, 434, 436, 439 & 440: NMES Indications: Maintain or increase the range of motion Prevention or retardation of disuse atrophy Re-educate muscles Relax muscle spasms Increase local blood circulation Prevention of venous thrombosis of the calf muscles immediately after surgery TENS Indications: Symptomatic relief and management of chronic, intractable pain Relief of pain associated with arthritis Adjunctive treatment in the management of post-surgical and post-trauma pain Adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee (models 431, 432 and 433 only) In Neuromuscular Electrical Stimulation (NMES) only mode, models 437 & 441: Maintain or increase the range of motion Prevention or retardation of disuse atrophy Re-educate muscles Relax muscle spasms Increase local blood circulation Prevention of venous thrombosis of the calf muscles immediately after surgery In Transcutaneous Electrical Nerve Stimulation (TENS) only mode, model 438: Symptomatic relief and management of chronic, intractable pain Relief of pain associated with arthritis Adjunctive treatment in the management of post-surgical and post-trauma pain

Source page: https://510kreport.com/device/K112258
Methodology: https://510kreport.com/methodology