Shenzhen Osto Medical Technology Company Limited
Manufacturer and brand owner in Shenzhen, Guangdong, China. 11 device types, 28 products catalogued, 13 clearances.
Shenzhen Osto Medical Technology Company Limited is a repacker / relabeller holding a current FDA establishment registration. The registration covers Device, Rebreathing, Pad, Heating, Powered and 9 other device types. 28 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2014.
11device types registered with the FDA
28products catalogued under its own name
13510(k) clearances
Registration
| Registered name | Shenzhen OSTO Medical Technology Company Limited |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011564440 |
| FEI number | 3011564440 |
| DUNS | 528161684 |
| Establishment type | Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 深圳市奥斯拓医疗科技有限公司 |
|---|---|
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 2104, Unit4, Building2, Zhongxin Longsheng Square, NO. 219 Shenshan Road |
| Postal code | 518116 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Device, Rebreathing | Class 1 | Oxygen concentrator concentrator, Model No: AST -608, AST-809, AST-809 | 2023 | 13 |
| Light Based Over The Counter Wrinkle Reduction | Class 2 | LED Facial Mask, Model: AST-804, AST-804A, AST-804B, AST-805, AST-805A, AST-805B, Promote absorption of skin care products, Penguin 4 LED Light Platinum Therapy Face Mask (Prospera DL038 reference to AST-804B), LED Facial Mask, Anti-wrinkle, Acne treatment, Model No AST-H606; LED Facial Wand Model No D103, Anti-wrinkle, | 2022 | 67 |
| Massager, Therapeutic, Electric | Class 1 | AST-213, AST-214, AST-E10, Air Pressure Foot MassagerAST-X10, AST-X10B, AST- X11, AST-X11B,AST-X12,AST-X20; Eye massager Model AST-211, AST-212, Knee Massager AST-649, hand massager AST-H61 | 2022 | 437 |
| Massager, Therapeutic, Manual | Class 1 | Multifunctional beauty device AST-B60 | 2026 | 113 |
| Over-The-Counter Powered Light Based Laser For Acne | Class 2 | LED Facial Mask, Model: AST-804, AST-804A, AST-804B, AST-805, AST-805A, AST-805B, Promote absorption of skin care products, Penguin 4 LED Light Platinum Therapy Face Mask (Prospera DL038 reference to AST-804B), LED Facial Mask, Anti-wrinkle, Acne treatment, Model No AST-H606; LED Facial Wand Model No D103, Anti-wrinkle, | 2022 | 59 |
| Pad, Heating, Powered | Class 2 | Heating Lumbar Therapy Cushion (model: AST-622, AST-622B, AST-623, AST-623B), Low-frequency stimulator (Model AST-645, AST-646) | 2021 | 144 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | Class 2 | Low-frequency stimulator (Model AST-645, AST-646) | 2021 | 22 |
| Stimulator, Muscle, Powered | Class 2 | Low-frequency stimulator (Model AST-645, AST-646) | 2021 | 33 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | Class 2 | Physiotherapy instrument, AST-2011A, AST-2011B, AST-802B, Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303), Heating Lumbar Therapy Cushion (model: AST-622, AST-622B, AST-623, AST-623B), Low-frequency stimulator (Model AST-645, AST-646), Neck Care Therapy and 9 more | 2014 | 66 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | Class 2 | Low-frequency stimulator (Model AST-645, AST-646) | 2021 | 32 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | Class 2 | Physiotherapy instrument, AST-2011A, AST-2011B, AST-802B, Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303), Heating Lumbar Therapy Cushion (model: AST-622, AST-622B, AST-623, AST-623B), Low-frequency stimulator (Model AST-645, AST-646), Neck Care Therapy and 9 more | 2014 | 57 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 15 |
| Osito | NGX | 11 |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 4 |
| Creliver | NGX | 3 |
| Vevor | NGX | 3 |
| Be-Younger | NGX | 2 |
| Osito | NUH | 2 |
| capillus | OLP | 2 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 |
| Auxoliev | NGX | 2 |
| Mdibzca | NGX | 1 |
| Creliver | IRT | 1 |
| caring mill | NGX | 1 |
| Circulation maxx | NGX | 1 |
| Umitec | OLP | 1 |
| Goyibam | NGX | 1 |
| Easezen | NGX | 1 |
| Light Based Over The Counter Wrinkle Reduction | OHS | 1 |
| Pad, Heating, Powered | IRT | 1 |
| Circulation Plus | NGX | 1 |
| Osto | NUH | 1 |
| Advanced Foot Energizer | NGX | 1 |
| Sumot | NGX | 1 |
| LumaDoc | OLP | 1 |
| Circulation Plus Reviver | NGX | 1 |
| North American Health+Wellness | NGX | 1 |
| Allwolf | NGX | 1 |
| Osto | NGX | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K261131 | 2026-09-06 | NUH | Traditional | This company |
| K213056 | 2022-07-07 | OLP | Traditional | This company |
| K211942 | 2021-12-13 | NGX | Traditional | This company |
| K212989 | 2021-11-22 | NUH | Traditional | This company |
| K211736 | 2021-09-05 | NUH | Traditional | This company |
| K210756 | 2021-06-11 | NUH | Traditional | This company |
| K190783 | 2020-03-14 | NUH | Traditional | This company |
| K190673 | 2019-12-12 | NUH | Traditional | This company |
| K182136 | 2019-10-10 | NUH | Traditional | This company |
| K172897 | 2018-12-07 | NUH | Traditional | This company |
| K172837 | 2018-11-26 | NUH | Traditional | This company |
| K172834 | 2018-09-06 | NUH | Traditional | This company |
| K133929 | 2014-11-12 | NUH | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2005 |
|---|---|
| Factory area | 10000 |
| Main products | TENS/EMS devices, foot massagers, massage devices, light therapy devices |
| Certifications | ISO 13485, CE, FDA, TGA, FCC, ROHS, BSCI |
| Export markets | 50+ countries |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.