Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012657194

FEI Number

3012657194

Entity Name

SHENZHEN FITTOP HEALTH TECHNOLOGY CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

3, 6, 8/F, BLDG 3, No.7, LangFeng Road, Xinshi, Community, Dalang, Longhua District,, Shenzhen Guangdong 518000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Fittop Health Technology Co., Ltd. (Owner Number: 10060590)

Owner / Operator Contact Address

3, 6, 8/F, BLDG 3, No.7, LangFeng Road, Xinshi, Community, Dalang, Longhua District,, Shenzhen, CN-GD 518000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001- RBMASK, FCM910) MASK, SCAVENGING Respirator, surgical Neck Massager; Accuvibe Mini Massager, therapeutic, electric

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2025-08-25
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2025-08-25
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2025-08-25
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-03
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-31
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2019-05-29

Official Correspondent

Wei Huang

US Agent Details

Kai Li Email: likai323@hotmail.com Phone: (501) 7778490

Related Public Records

Same Entity

Shenzhen Fittop Health Technology Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012657194. Last updated year: 2026. Please use registration number 3012657194 when referencing this establishment in official correspondence.