# K971542: Ortho DX Neuromuscular Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Rehabilicare, Inc.
- Decided: Aug 14, 1997 after 108 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: 1 generation back to K840346 (1984). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881082: GV 11 (TM), Model 9700, Medical Devices, Inc. (1988) Summary page 1.
- K840346: Neuromusclar II, Mentor Corp. (1984) Summary page 1.
- (no number) TRI-STIM Stimulator, Muscle, Electrical Powered: named in the summary without a submission number

## Most influential descendants
- K021905: Classic NMS (2002), 1 descendant of its own
- K091236: Mantra Combo, Model Mecs 320 (2009), 0 descendants of its own
- K030403: Cefar Rehab 2 and Rehab 2 Pro (2003), 0 descendants of its own
- K020637: Select Stim (2002), 0 descendants of its own

## Indications for use
The Ortho Dy, a non-invasive electrical stimulator that combines symmetrical biphasic neuromuscular stimulation with high volt pulsed direct current neuromuscular stimulation to be used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. It is used to, relax muscle spasm, prevent or retard disuse atrophy, increase local blood circulation, reeducate muscles, prevent venous thrombosis with immediate post surgical stimulation in calf muscles, and increase range of motion.

Source page: https://510kreport.com/device/K971542
Methodology: https://510kreport.com/methodology