# K083735: Ansha Autonomic Nervous System Health Assessment Plus

- Pathway: 510(k) (Traditional)
- Applicant: Medtechs, LLC
- Decided: Feb 18, 2009 after 64 days
- Product code: JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic)
- Device class: 2
- Regulation: 21 CFR 870.2780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K853124 (1985). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073323: SA-3000P, Medicore Co., Ltd. (2007) Summary page 1.
- K080884: QHRV 1 - Health Assessment System, Medtechs, LLC (2008) Summary page 1.

## Most influential descendants
- K101983: Critical Care Assessment (2010), 1 descendant of its own
- K191266: VitalScan ANS (2020), 0 descendants of its own

## Indications for use
ANSHA (QHRV1) is intended for noninvasive measurements of pulse waveforms by photoelectric plethysmography and heart rate by electrocardiograph. The system is intended for use of patients in medical clinics, healthcare practices and in out-patient department of hospitals.

Source page: https://510kreport.com/device/K083735
Methodology: https://510kreport.com/methodology