Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011564440

FEI Number

3011564440

Entity Name

Shenzhen OSTO Medical Technology Company Limited

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

2104, Unit4, Building2, Zhongxin Longsheng Square, NO. 219 Shenshan Road, Longgang Street, Longgang District,, Shenzhen Guangdong 518116, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen OSTO Medical Technology Company Limited (Owner Number: 10048304)

Owner / Operator Contact Address

2104, Unit4, Building2, Zhongxin Longsheng Square, NO. 219 Shenshan Road (Longgang Section), Longxin Community, Baolong Street, Longgang District, Shenzhen City, CN-GD 518116, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211942

PMA Number

N/A

All Registered Proprietary Names

Circulation Plus-Health Expert Electronic Stimulator (Model: AST-300C, AST-300D) Advanced Foot Energizer-Health Expert Electronic Stimulator (Model: AST-300C, AST-300D) Neck Care Therapy AST-905B Health Expert Electronic Stimulator (model: AST-300L) Multifunctional beauty device AST-B60 LED Facial Mask, Anti-wrinkle, Acne treatment, Model No AST-H606; LED Facial Wand Model No D103, Anti-wrinkle, Penguin 4 LED Light Platinum Therapy Face Mask (Prospera DL038 reference to AST-804B) LED Facial Mask, Model: AST-804, AST-804A, AST-804B, AST-805, AST-805A, AST-805B Promote absorption of skin care products Low-frequency stimulator (Model AST-645, AST-646) Low-frequency Multi-function physiotherapy instrument AST-603, AST-2012A, AST-2012B NECK CARE THERAPY (model: AST-905A, AST-905D, AST-905H) AST-2011A, AST-2011B, AST-802B Physiotherapy instrument Health Expert Electronic Stimulator-AST-300F, AST-300H, AST-300J Heating Lumbar Therapy Cushion (model: AST-622, AST-622B, AST-623, AST-623B)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2014-12-28
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2014-12-28
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2019-01-19
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2019-01-19
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2020-06-08
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2020-06-08
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2026-01-30
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2022-07-24
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2022-07-24
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2021-11-23
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2021-11-23
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2021-11-23
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2021-11-23
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2021-11-23
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2021-11-23
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2019-01-19
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2019-01-19
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2021-08-05
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2021-08-05
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2019-01-19
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2019-01-19
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2019-12-20
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2019-12-20
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2022-05-30
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2022-05-30
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2022-05-30

Official Correspondent

Yang Lee

US Agent Details

Manoj Zacharias Business: Liberty Management Group Ltd. Email: jettlenn@outlook.com Phone: (630) 2702921

Related Public Records

Same Entity

Shenzhen OSTO Medical Technology Company Limited

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
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31
K122948	Gemore Technology Co, Ltd.	GEM-STIM COMBO STIMULATOR	2012-12-21
K033455	Biomedical Life Systems, Inc.	ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5	2004-01-15
K810593	Medical Devices, Inc.	NEUROPAC ULTRA I	1981-03-13
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011564440. Last updated year: 2026. Please use registration number 3011564440 when referencing this establishment in official correspondence.