# K150413: QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Cymedica Orthopedics, Inc.
- Decided: Apr 2, 2015 after 43 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: 5 generations back to K010335 (2001). 18 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110350: Kneehab XP, Bio-Medical Research, Ltd. (2011) Summary page 5.
- K082011: Medistim XP, Type 281 and Meditens XP, Type 458, Bio-Medical Research, Ltd. (2008) Summary page 5.

## Most influential descendants
- 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
- K240992: eMVFit (MVF-10M) (2024), 0 descendants of its own

## Indications for use
The QB1 Powered Muscle Stimulator System (NMES) &Transcutaneous Electrical Nerve Stimulator System (TENS); QB-1000 is a multifunctional electrotherapy device with two treatment modes that allow for neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS). Indications for Use: As an NMES device, indications are for the following conditions: - Relaxation of muscle spasms - Retardation or prevention of disuse atrophy - Increasing local blood circulation - Re-educating muscles - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion As a TENS device, indications are for the following conditions: - Symptomatic relief and management of chronic intractable pain - Adjunctive treatment for post-surgical and post-trauma acute pain

Source page: https://510kreport.com/device/K150413
Methodology: https://510kreport.com/methodology