Foshan Pingchuang Medical Technology Co., Ltd.
Manufacturer and brand owner in Foshan, Guangdong, China. 9 device types, 3 products catalogued, 3 clearances.
Foshan Pingchuang Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Bag, Ice, Enema Kit and 7 other device types. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
9device types registered with the FDA
3products catalogued under its own name
3510(k) clearances
Registration
| Registered name | FOSHAN PINGCHUANG MEDICAL TECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014317667 |
| FEI number | 3014317667 |
| DUNS | 540356882 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 佛山市平创医疗科技有限公司 |
|---|---|
| Unified social credit code | 91440606059951820B |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Foshan |
|---|---|
| Province | Guangdong |
| Address | Building B,Floors 1-4,No.13,Honggang Section,Liandu Avenue,HonggangCommunity,DaliangSubdistrict,ShundeDistrict |
| Postal code | 528312 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Bag, Ice | Class 1 | ICE Pack (PCICE-1,PCICE-2,PCICE-3,PCICE-4) | 2020 | 86 |
| Douche Apparatus, Vaginal, Therapeutic | Class 1 | Vaginal douche apparatus, Model: 50ml, 80ml, 135ml, 150ml | 2026 | 20 |
| Elastomer, Silicone, For Scar Management | Class 1 | Silicone Scar Removal Sheets(8cm*3cm,10cm*3cm,12cm*3cm,12cm*6cm,12cm*8cm,20cm*3cm,20cm*12cm,20cm*16cm) | 2021 | 85 |
| Enema Kit | Class 1 | Enema Kit, Model: 80ml, 120ml, 150ml | 2026 | 24 |
| Fiber, Medical, Absorbent | Class 1 | OHC Measuring&Cold Nursing Pad (PC-NO,PC-CA,PC-CO) | 2020 | 172 |
| Lubricant, Patient | Class 1 | Body Lubricant (PC-LU-A, PC-LU-B, PC-LU-C, PC-LU-D, PC-LU-E, PC-LU-F), Hybrid personal lubricant (water&silicone) | 2020 | 33 |
| Lubricant, Personal | Class 2 | VeletGlide Water soluble personal lubricant, XESSO Water-based Lube, Water-soluble Personal Lubricant(5ml,10ml,20ml,30ml,50ml,60ml,80ml,100ml), Water-soluble Personal Lubricant(120ml,150ml,180ml,200ml,250ml,360ml,455ml,500ml,1L,5L), just for us water-based personal lubricant, Xmoment Water soluble personal lubricant and 3 more | 2021 | 15 |
| Media, Coupling, Ultrasound | Class 2 | Non-Sterile Ultrasound Gel Sterile Ultrasound Gel, MOD: 250g, 300g, 500g, 1Kg, 1.25L, 1.3L, 2.5L, 5L, Non-Sterile Ultrasound Gel Sterile Ultrasound Gel, MOD: 5g,8g,10g,12g,15g,20g,30g,50g,82g,100g,120g,150g,180g,200g | 2026 | 8 |
| Support Gels | Class 1 | Ultrasound Gel, Model PC-MU, PC-MUS, PC-MUST (10g,12g,15g,20g,60g,80g,100g,250g,1L,5L), Ultrasound Gel, Model CP-S12J, CP-S12P, CP-S15, CP-S20G, CP-S30, SP-S250 (10g,12g,15g,20g,60g,80g,100g,250g,1L,5L) | 2020 | 4 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Fapdale; Water soluble personal lubricant | NUC | 2 |
| Jomani; Water soluble personal lubricant | NUC | 1 |
| Just for us; Water based personal lubricant | NUC | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K253255 | 2026-06-17 | MUI | Traditional | This company |
| K252935 | 2025-12-15 | NUC | Traditional | This company |
| K212104 | 2021-11-18 | NUC | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2012 |
|---|---|
| Factory area | 13000 m2 |
| Main products | personal lubricant, ultrasound gel, photon cold gel, moisturizing gel, scar gel |
| Certifications | ISO13485, FDA, CE, RoHS |
| Export markets | Europe, United States, Japan, 39 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.