Shenzhen Pango Medical Electronics Co., Ltd.
Registered establishment in Shenzhen, Guangdong, China. 6 device types, 3 clearances.
Shenzhen Pango Medical Electronics Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Orthosis, Lumbar, Sleeve, Limb, Compressible and 4 other device types. Its earliest product listing with the FDA dates from 2011.
Registration
| Registered name | Shenzhen Pango Medical Electronics Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006792041 |
| FEI number | 3006792041 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 深圳攀高医疗电子有限公司 |
|---|---|
| Unified social credit code | 914403007152678254 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | No. 25, 1st Industry Zone, Fenghuang Road |
| Postal code | 518115 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Continuous Measurement Thermometer | Class 2 | PARAMED ear & forehead thermometer PG-IRT1603, Procare PG-IRT1602, Lakmus PRO PG-IRT1602, SeemtraMed PG-IRT1603, JNK-TM-399 = PG-IRT1603, Infrared thermometer PG-IRT1602 and 16 more | 2019 | 115 |
| Hearing Aid, Air-Conduction, Prescription | Class 1 | Digital Hearing Aid-PG-Z203, Digital Hearing Aid-PG-Z108-1, Digital Hearing Aid-PG-Z106-1, Digital Hearing Aid-PG-Z104-1, Digital Hearing Aid-PG-Z106-2, Digital Hearing Aid-PG-Z106BT-2 and 13 more | 2022 | 45 |
| Massager, Therapeutic, Electric | Class 1 | PG-2404G intelligent eye massage, BRM-5800 Silicon Facial Cleaner, Scalp Massager(PG-2701,PG-2704), Body Sport BDSM300 = PG-2404G5, PG-2015F1 Portable Air Compression Leg Massager, Body Sport BDSM400 = PG-2701 and 22 more | 2012 | 437 |
| Orthosis, Lumbar | Class 1 | Intelligent Waist and Abdomen Massager(Waist M5) | 2023 | 110 |
| Sleeve, Limb, Compressible | Class 2 | 2021 | 24 | |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | Electronic Blood Pressure Monitor PG-800B18, PG-800B19, PG-800B19L, PG-800B28, PG-800B29, PG-800B51, PG-800B9, Electronic Blood Pressure Monitor, CBPM002 = PG-800B9, PG-800B11=TM-BP2000, 22-52cm cuff 22-42cm cuff and 71 more | 2011 | 98 |
Clearances
3 clearances name Shenzhen Pango Medical Electronics Co., Ltd. as applicant. 9 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K240729 | 2024-06-14 | DXN | Traditional | This company |
| K223291 | 2023-06-14 | DXN | Traditional | This company |
| K212346 | 2022-05-05 | FLL | Traditional | This company |
| K203746 | 2021-11-10 | JOW | Traditional | Shenzhen Pango Electronic Co., Ltd. |
| K200716 | 2020-12-04 | DXN | Traditional | Shenzhen Pango Electronic Co., Ltd. |
| K182597 | 2019-04-03 | FLL | Traditional | Shenzhen Pango Electronic Co., Ltd. |
| K170151 | 2017-10-13 | DXN | Special | Shenzhen Pango Electronic Co., Ltd. |
| K161845 | 2017-07-31 | DXN | Special | Shenzhen Pango Electronic Co., Ltd. |
| K131558 | 2013-08-30 | DXN | Traditional | Shenzhen Pango Electronic Co., Ltd. |
| K131569 | 2013-06-14 | DXN | Traditional | Shenzhen Pango Electronic Co., Ltd. |
| K102988 | 2010-11-09 | DXN | Traditional | Shenzhen Pango Electronic Co., Ltd. |
| K102920 | 2010-10-15 | DXN | Traditional | Shenzhen Pango Electronic Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1992 |
|---|---|
| Employees | 1000 |
| Factory area | 10,000m² |
| Main products | EMS TENS Therapy devices, Blood Pressure Monitors, Infrared Thermometers, Nebulizers, Pulse Oximeters |
| Certifications | ISO 13485:2016, CE, FDA, ROHS, CE0197, CE2862 |
| Export markets | 60+ 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.