# K083164: System-Arms, Models 390, X60

- Pathway: 510(k) (Special)
- Applicant: Bio-Medical Research, Ltd.
- Decided: Dec 16, 2008 after 50 days
- Product code: NGX (Stimulator, Muscle, Powered, For Muscle Conditioning)
- 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: 4 generations back to K010335 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071666: Slendertone Enervive, Model 561, Bio-Medical Research Corp. (2008) Summary page 1.
- K072553: System-Arms, Model 390,E60, Bio-Medical Research, Ltd. (2007) Summary page 1.

## Indications for use
System Arms (Type 390, X60) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance of the triceps and biceps muscles.

Source page: https://510kreport.com/device/K083164
Methodology: https://510kreport.com/methodology