# 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

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kentro Medical Electronics Co., Ltd.
- Decided: May 10, 2023 after 230 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: 2 generations back to K210825 (2021). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220998: Transcutaneous Electrical Nerve Stimulator, Model: KTR-405, Shenzhen Kentro Medical Electronics Co., Ltd. (2022) Summary page 5.

## 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/K222870
Methodology: https://510kreport.com/methodology