# K972244: NT2000

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Medical Research, Ltd.
- Decided: Feb 27, 1998 after 256 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 K912178 (1991). 1 ancestor in all.
80 later devices descend from it; 2 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912178: Bio Tens 601, 606 and 608 (3000), Skylark Device Co., Ltd. (1991) 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
The NT2000 is indicated for: a) Transcutaneous Electrical Nerve Stimulation (TENS) for the symptomatic relief and management of chronic (long term) intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems. b) Electrical Neuromuscular Stimulation for the purposes of relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle re-education, increase local blood circulation, maintain or increase range of motion, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Source page: https://510kreport.com/device/K972244
Methodology: https://510kreport.com/methodology