K-number	K250033
Device name	Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)
Applicant	Guangzhou Pinzhi Medical Technology Co., Ltd.
Product code	NUH
Device class	Class II
Decision date	Apr 7, 2025
Decision	Substantially Equivalent
Regulation	882.5890

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

Smart Pulse Relief is a transcutaneous electrical nerve stimulator (TENS) and electrical muscle stimulator (EMS) device. The PZ-2622 model includes both TENS modes (1-12) for temporary pain relief in muscles and joints, and EMS modes (13-24) for muscle stimulation and performance enhancement. The PZ-2622T is TENS-only and PZ-2622E is EMS-only variants. All are over-the-counter devices intended for home use on upper and lower extremities.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary. The document confirms substantial equivalence was determined based on comparison to legally marketed predicate devices, but does not provide the specific predicate device names, performance data, or the comparative reasoning that supported the SE determination.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)

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