510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253932Substantially Equivalent

FACEGYM Pro Device (HD-109)

Shenzhen Kaiyan Medical Equipment Co., Ltd, Shenzhen, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253932 is the FDA 510(k) clearance record for FACEGYM Pro Device (HD-109), a class II device, cleared for Shenzhen Kaiyan Medical Equipment Co., Ltd. on under FDA product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes). FDA records list 24 510(k) clearances for Shenzhen Kaiyan Medical Equipment Co., Ltd., from to . As of , FDA records show no recalls naming K253932.

Clearance record

Decision date
Received
(226 days to decision)
Product code
NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
Shenzhen Kaiyan Medical Equipment Co., Ltd. Bldg.#3 And Bldg.#5, 40th Of Fuxin St., Shenzhen, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NFO

Trailing 12 months
9 clearances under product code NFO in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code NFO, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20260
April 20260
May 20262
June 20261
July 20261
August 20261
September 20262
October 20260