Shenzhen XFT Medical Limited
Manufacturer and brand owner in Shenzhen, Guangdong, China. 8 device types, 4 products catalogued, 4 clearances.
Shenzhen XFT Medical Limited is a manufacturer holding a current FDA establishment registration. The registration covers Device, Biofeedback, Exerciser, Finger, Powered and 6 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2009.
Registration
| Registered name | SHENZHEN XFT MEDICAL LIMITED |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3004438577 |
| FEI number | 3004438577 |
| DUNS | 526874312 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳讯丰通医疗股份有限公司 |
|---|---|
| Unified social credit code | 914403007247175848 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Block B, Building 4, Shenzhen Biomedicine Innovations Industrial Park |
| Postal code | 518118 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | Class 2 | XFT, Suction Rescue Device, Model: XFT-2015A, XFT-2015B | 2024 | 30 |
| Device, Biofeedback | Class 2 | XFT, Nerve And Muscle Stimulator, Model XFT-2003K | 2021 | 6 |
| Device, Incontinence, Urosheath Type, Non-Sterile | Class 1 | Pelvic muscle trainer XFT-0010CK | 2012 | 13 |
| Exerciser, Finger, Powered | Class 1 | XFT, Rehabilitation Robot, XFT-2005A | 2025 | 9 |
| Massager, Therapeutic, Electric | Class 1 | XFT | 2009 | 437 |
| Stimulator, Muscle, Powered | Class 2 | XFT, Nerve And Muscle Stimulator, model XFT-2000, SaeboStim Pro, Nerve And Muscle Stimulator, model XFT-2000, XFT, Nerve And Muscle Stimulator, Model XFT-2003K | 2020 | 33 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | Class 2 | XFT, Nerve And Muscle Stimulator, model XFT-2000, SaeboStim Pro, Nerve And Muscle Stimulator, model XFT-2000 | 2020 | 32 |
| Stimulator, Neuromuscular, External Functional | Class 2 | XFT, Nerve And Muscle Stimulator, Model XFT-2001E, XFT-2001EA, XFT, Foot Drop System, Model XFT-2001D | 2017 | 8 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| XFT | GZI | 3 |
| Aspire | HCC | 1 |
| XFT, SaeboStim Pro | IPF | 1 |
| XFT | IPF | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K211094 | 2021-07-08 | IPF | Traditional | This company |
| K193276 | 2020-09-23 | GZI | Traditional | This company |
| K193275 | 2020-04-11 | IPF | Traditional | This company |
| K162718 | 2017-11-30 | GZI | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2000 |
|---|---|
| Factory area | 10000 m² |
| Main products | Foot Drop System, Hand Rehab System, Pelvic Muscle Trainer, EMG Biofeedback FES, AED/CPR Training devices |
| Certifications | ISO13485, CE, FDA, NMPA |
| Export markets | 80+ countries |
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.