Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)

The Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) is an electro-acupuncture device powered by six 1.5V batteries or AC 100-240V. It consists of a console with operating controls and six electrode cable channels with alligator connectors. The device is indicated for use in acupuncture practice by qualified state-licensed practitioners and does not include acupuncture needles.

Both subject devices use the same fundamental voltage-controlled output technology as their predicates with identical power sources, isolation methods, channel configuration, and three output modes (continuous, interrupted, dense-disperse waves). Minor differences exist in maximum output voltage tolerances (±20% vs ±10%), pulse width specifications, and some indicator display features. Maximum current density and average power density remain within established safety limits.

ANSI AAMI ES60601-1:2005/(R)2012 with amendments (general medical electrical equipment safety), IEC 60601-1-2 Edition 4.1 (electromagnetic disturbances), and IEC TS 60601-4-2 Edition 1.0 (electromagnetic immunity guidance). The submission notes that IEC 60601-2-10 (neuromuscular stimulation standard) is not required because the BWK product code does not appear in FDA testing standards for this device classification.

The devices share identical fundamental design, same manufacturer, identical indications for use, same power sources, control methods, and output modes. Technical parameter differences (output voltage tolerances, pulse specifications, display features) are minor; calculated maximum current density and average power density do not exceed established safety limits. Both devices passed the same IEC 60601-1 and IEC 60601-1-2 safety standards, confirming no new safety or effectiveness issues despite minor specification variations.