# K013167: MODEL7500 Microcurrent Tens Device, MCT-F5, MCT-F50, MCT-F500

- Pathway: 510(k) (Traditional)
- Applicant: Newcare Products, LLC
- Decided: Jan 30, 2002 after 131 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: 3 generations back to K912178 (1991). 8 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003507: Medrelief, Healthonics, Inc. (2001)
- K990787: TRIO 300, Ito Co., Ltd. (1999) Summary page 1.
- (no number) Advance Medequip Model 850 Microcurrent TENS device: named in the summary without a submission number

## Most influential descendants
- K090042: Painmaster MCT Patch (2009), 11 descendants of its own
- K130114: Painmaster MCT Patch (2013), 5 descendants of its own
- K120500: The Pain Pilot (a.K.a Pain Pilot) (2012), 4 descendants of its own
- K152852: ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) (2015), 2 descendants of its own
- K133789: Dolphin Neurostim Otc (2015), 1 descendant of its own

## Indications for use
The subject device is intended to be used for the symptomatic relief of chronic intractable pain.

Source page: https://510kreport.com/device/K013167
Methodology: https://510kreport.com/methodology