# K052309: Digital Hand Dynamometer, Model SH5003; Digital Pinch Gauge, Model SH5006

- Pathway: 510(k) (Traditional)
- Applicant: Saehan Corp.
- Decided: Sep 27, 2005 after 34 days
- Product code: LBB (Dynamometer, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 888.1240
- 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 K042889 (2004). 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)
- K042889: Dynamometer - Model Fce and Model MSC, Ametek (2004) Summary page 1.

## Indications for use
The SH5003 & SH5006 Digital Hand Dynamometer & Digital Pinch Gauge are for performing manual muscle testing to measure grip or pinch strength in an injured and uninjured.

Source page: https://510kreport.com/device/K052309
Methodology: https://510kreport.com/methodology