# K980866: Medi-DX 7000 CPT with Amrex Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Neuro-Diagnostic Assoc.
- Decided: May 20, 1998 after 90 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- 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 1.

## Indications for use
The Medi-Dx 7000 is a diagnostic device for the quantitative detection of sensory neurological impairments. The population of subjects for whom this device may be used for diagnostic purposes would include any Individual capable of communicating their perception of cutaneous sensation. The Medi-Dx 7000 diagnostic examination may be conducted as part of 2 routine neurological examination or as a screening procedure for the detection of peripheral neuropathy which may be caused by various pathological conditions or exposures to toxic substances.

Source page: https://510kreport.com/device/K980866
Methodology: https://510kreport.com/methodology