# K962239: Smart Adjuster (SA201)

- Pathway: 510(k) (Traditional)
- Applicant: Sigma
- Decided: Jan 10, 1997 after 213 days
- Product code: LXM (Manipulator, Plunger-Like Joint)
- Device class: U
- 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 K940085 (1994). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940085: Force Recording and Analysis System, Model 01, Sense Technology, Inc. (1994) Summary page 1.

## Most influential descendants
- K160278: VSTAAR AdjusteR (2016), 0 descendants of its own
- K050428: Technology-Assisted Micro-Mobilization and Reflex Stimulator (Tamars) (2005), 0 descendants of its own

## Indications for use
This device will be used by chiropractors to as an additional analysis tool to help identify areas of fixation and/or subluxation of the human spine. Additionally, it will allow the doctors to perform mechanical adjustments to the human spine.

Source page: https://510kreport.com/device/K962239
Methodology: https://510kreport.com/methodology