# K951951: Focus Model 795 Unit

- Pathway: 510(k) (Traditional)
- Applicant: Empi
- Decided: May 17, 1996 after 387 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.
81 later devices descend from it; 6 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)
- None. The FDA summary names its predicate without a number.
- (no number) Empi Focus Model 727: named in the summary without a submission number
- (no number) Empi Respond Select: named in the summary without a submission number

## Most influential descendants
- K021100: 300 PV Complete Electrotherapy System (2002), 48 descendants of its own
- K093324: Empi Continuum (2010), 26 descendants of its own
- K124016: Empi Phoenix (2013), 25 descendants of its own
- K153704: Strive (2016), 24 descendants of its own
- K050991: The Odfs Dropped Foot Stimulator (2005), 20 descendants of its own

## Indications for use
As a TENS device, the Focus is indicated for the following conditions: symptomatic relief and management of chronic, intractable pain adjunctive treatment for post-surgical and post-trauma acute pain As a NMS/NMES device, the Focus is indicated for the following conditions: relaxation of muscle spasm prevention or retardation of disuse atrophy increasing local blood circulation muscle re-education prevention of venous thrombosis of the calf muscles immediately after surgery maintaining or increasing range of motion As a FES device, the Focus is indicated for the following condition: stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient’s gait

Source page: https://510kreport.com/device/K951951
Methodology: https://510kreport.com/methodology