Sanomedics International Holdings Inc. (fka SIMH)

[DaReal]

Doesn't seem to be designed by Thermomedics...
read the FDA Approval for the Caregiver unit.
They used an already manufactured and FDA approved Thermometer from TaiDoc and applied basically just some SW changes to it:

Predicate device name:
U-RIGHT TD-1240 Thermometer


Comparison with predicate:
Caregiver Professional Clinical Thermometer (Model PRO-TF300)

has the following similarities to the predicate device:

- same operating principle
- same fundamental scientific technology
- incorporate the same basic circuit design
- incorporate the same materials
- same shelf life
- manufactured by the same process

The modifications encompass:
- displayed temperature range
- memory storage capacity
- modification in the physical appearance
- a modification in the user interface
- labeling change due to the modifications

http://www.accessdata.fda.gov/cdrh_docs/pdf13/K131771.pdf

If you call those minor changes DESIGN...