# K220998: Transcutaneous Electrical Nerve Stimulator, Model: KTR-405

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kentro Medical Electronics Co., Ltd.
- Decided: Aug 24, 2022 after 142 days
- Product code: NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)
- 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 K210825 (2021). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210825: Revitive Medic Coach (Model Number 5575AQ), Actegy, Ltd. (2021) Summary page 5.

## Most influential descendants
- K222870: Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039 (2023), 0 descendants of its own

## Indications for use
1) When using Electrical Muscle Stimulation, Transcutaneous Electrical Nerve Stimulator is intended: for users with conditions or disease that are associated with impaired (poor) blood flow in the legs/ ankles/ feet, the device through the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping to temporarily increase local blood circulation in healthy leg muscles to stimulate healthy muscles in order to improve and facilitate muscle performance to temporarily relieve pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities(legs) due to strain from exercise or normal household duties to relax muscle spasm to increase blood flow circulation for prevention of retardation of disuse atrophy for muscle re-education for maintaining or increasing range of motion Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Provide quadricep strengthening Improve knee stability secondary to quadricep strengthening 2) When using Transcutaneous Electrical Nerve Stimulator to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide: symptomatic relief and management of chronic, intractable pain relief of pain associated with arthritis temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties

Source page: https://510kreport.com/device/K220998
Methodology: https://510kreport.com/methodology