# K982410: SMP-Plus,SX-Plus,SX Model # 49XX Series 9 Volt Tens Device

- Pathway: 510(k) (Traditional)
- Applicant: Rehabilicare, Inc.
- Decided: Nov 6, 1998 after 116 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
No predicates in its family tree.
25 later devices descend from it; 4 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SMP, Model 48008, Transcutaneous Electrical Nerve Stimulator, Rehabilicare, Inc.: named in the summary without a submission number
- (no number) Ultrapac, Model 4500, Transcutaneous Electrical Nerve Stimulator, Rehabilicare: named in the summary without a submission number
- (no number) MAXIMA 111, Transcutaneous Electrical Nerve Stimulator, Stayodyn, Inc.: named in the summary without a submission number

## Most influential descendants
- K011702: Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, Sgxxx (2001), 14 descendants of its own
- K022241: Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG 102-XXX (2002), 13 descendants of its own
- K061166: Deepwave Percutaneous Neuromodulation Pain Therapy System (2006), 12 descendants of its own
- K072123: Homewave Neuromodulations Pain Therapy Device (2008), 11 descendants of its own
- K161154: Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs (2016), 9 descendants of its own

## Indications for use
TENS stimulation is used for symptomatic relief and management of chronic intractable pain. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain. [t has no curative value and should be used only in conjunction with medical supervision.

Source page: https://510kreport.com/device/K982410
Methodology: https://510kreport.com/methodology