Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K250033 · 2025-04-07

ApplicantGuangzhou Pinzhi Medical Technology Co., Ltd.
Decision Date2025-04-07
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) is a medical device manufactured by Guangzhou Pinzhi Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-07 under approval number K250033. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)?

Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) is a medical device that received FDA 510(k) clearance on 2025-04-07. It is manufactured by Guangzhou Pinzhi Medical Technology Co., Ltd.. The 510(k) number is K250033.

When was Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) approved by the FDA?

Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) received FDA 510(k) clearance on 2025-04-07, under approval number K250033.

What company makes Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)?

Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) is manufactured by Guangzhou Pinzhi Medical Technology Co., Ltd..

What is the FDA product code for Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)?

The FDA product code for Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) is NUH.

Related Devices (Code: NUH)

K162630CP Relief Wand-OTCMid-America Medical Innovations, LLC K161453WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605AWell-Life Healthcare Limited K160508Electronic Pulse StimulatorBeijing Choice Electronic Technololgy Co., Ltd. K161537OTC TENS Device, Model PTS-IVCounter Scientific Development (Gz), Ltd. K151995Painmaster MCT PatchNewmark, Inc. K160255HBOTC Muscle and Nerve StimulatorHb Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑