# K160052: CUR Model 1

- Pathway: 510(k) (Traditional)
- Applicant: Thimble Bioelectronics, Inc.
- Decided: May 20, 2016 after 130 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: 7 generations back to K881114 (1988). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140333: Ascend, Neurometrix, Inc. (2014). Our reading of the summary gave K104333, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “NeuroMetrix ASCEND”. Summary page 7.
- K151035: PulseRelief, Philips Consumer Lifestyle (2015) Summary page 4.

## Most influential descendants
- K233784: ENSO (Model 2) (2024), 0 descendants of its own

## Indications for use
A transcutaneous electrical nerve stimulation (TENS) Mode which is indicated for the symptomatic relief and management of chronic intractable pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. , and A powered muscle stimulation (PMS) mode which is indicated to improve and facilitate muscle performance in healthy muscles. The CUR Model 1 should be applied to normal, healthy, dry and clean skin of adult patients.

Source page: https://510kreport.com/device/K160052
Methodology: https://510kreport.com/methodology