# K981976: Acutron Mentor Model 961

- Pathway: 510(k) (Traditional)
- Applicant: Microcurrent Research, Inc.
- Decided: Nov 25, 1998 after 177 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: 1 generation back to K880042 (1988). 3 ancestors in all.
79 later devices descend from it; 1 cites it directly.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880042: Acutron, Davis Assoc. (1988) Summary page 1.
- K932868: Theratouch 4.7, Rich-Mar Corp. (1994) Summary page 1.
- K941577: Dynatron 550, Dynatronics Corp. (1995) Summary page 1.

## Most influential descendants
- K990787: TRIO 300 (1999), 78 descendants of its own
- K023231: Elfcare Device, Models 314A Through 314G (2003), 63 descendants of its own
- K063715: Juniper Cooling Device Xtra (2007), 35 descendants of its own
- K072152: Juniper CLN1 Dermal Cooling Device (2007), 34 descendants of its own
- K080118: Zeltiq Aesthetics CLN1 Dermal Cooling Device (2008), 33 descendants of its own

## Indications for use
Symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain.

Source page: https://510kreport.com/device/K981976
Methodology: https://510kreport.com/methodology