# K072882: Pain Vision, Model PS-2100

- Pathway: 510(k) (Traditional)
- Applicant: Osachi Co., Ltd.
- Decided: Jan 8, 2009 after 457 days
- Product code: LLN (Device, Vibration Threshold Measurement)
- Device class: 1
- Regulation: 21 CFR 882.1200
- 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 K853608 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K853608: Neurometer, Neurotron, Inc. (1986) Summary page 3.

## Indications for use
PS-2100 is a device for the quantitative detection of sensory neurological impairments. The population of subjects for whom this device may be used include any individual capable of communicating their perception of cutaneous sensation. PS-2100’s examination may be conducted as part of a routine neurological examination or as a screening procedure. This device may be used by healthcare professionals to evaluate or diagnose a patient for peripheral neuropathy.

Source page: https://510kreport.com/device/K072882
Methodology: https://510kreport.com/methodology