# K250033: Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Pinzhi Medical Technology Co., Ltd.
- Decided: Apr 7, 2025 after 90 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
PZ-2622 is TENS and EMS Stimulator Mode 1-12: TENS: This mode 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. Mode 13-24: EMS: This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. PZ-2622E (Mode 1-24) is EMS Stimulator This device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. PZ-2622T (Mode 1-24) is TENS Stimulator This 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/K250033
Methodology: https://510kreport.com/methodology