# K130802: Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Dongdixin Technology Co., Ltd.
- Decided: Sep 16, 2013 after 178 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
No predicates in its family tree.
45 later devices descend from it; 7 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K171803: HIVOX OTC Electrical Stimulator (2017), 21 descendants of its own
- K151035: PulseRelief (2015), 20 descendants of its own
- K190347: HIVOX OTC Electrical Stimulator (2019), 8 descendants of its own
- K172079: Avail (2017), 5 descendants of its own
- K203574: HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 (2021), 4 descendants of its own

## Indications for use
MT9001 OTC TENS/EMS stimulator TENS: The device is designed to be used 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. EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. LT3060 OTC TENS stimulator TENS: The device is designed to be used 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.

Source page: https://510kreport.com/device/K130802
Methodology: https://510kreport.com/methodology