# K090866: Neurocalm Model 1 and 2

- Pathway: 510(k) (Traditional)
- Applicant: Neuromed Devices, Inc.
- Decided: Oct 21, 2009 after 204 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K881114 (1988). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072123: Homewave Neuromodulations Pain Therapy Device, Biowave Corporation (2008) Summary page 1.
- K071120: Aemed Stimpad Acu-Tens Transcutaneous Electrical Nerve Stimulator, Model 021999, Aemed, Inc. (2008) Summary page 1.

## Indications for use
The NeuroCalm Transcutaneous Electrical Nerve Stimulator Device is indicated for symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post-traumatic pain.

Source page: https://510kreport.com/device/K090866
Methodology: https://510kreport.com/methodology