Easymed Instruments Co., Ltd.
Manufacturer and brand owner in Daliang, Shunde, Foshan, Guangdong, China. 8 device types, 28 products catalogued, 3 clearances.
Easymed Instruments Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Stimulator, Muscle, Powered, Interferential Current Therapy and 6 other device types. 28 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2008.
Registration
| Registered name | EASYMED INSTRUMENTS CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3004049909 |
| FEI number | 3004049909 |
| DUNS | 526951168 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 佛山市顺德区依士文电子仪器有限公司 |
|---|---|
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Daliang, Shunde, Foshan |
|---|---|
| Province | Guangdong |
| Address | 3/F-6/F, Block A, No.4 |
| Postal code | 528300 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Interferential Current Therapy | Class 2 | Ultima NEO, IF-4 MultiWave | 2012 | 7 |
| Stimulator, Electrical, Non-Implantable, For Incontinence | Class 2 | Intrelief DN01 WH, Intrelief PFE, Intrelief DN01 GR, SoftCycle Exerciser | 2024 | 7 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | Class 2 | J-stim | 2013 | 22 |
| Stimulator, Muscle, Powered | Class 2 | Ultima NEO, IF-4 MultiWave, Ultima Combo, EasySTIM NMS-28 EMS Unit, NerveSpa Pro, Ampcare ES and 1 more | 2008 | 33 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | Class 2 | Intrelief Combo, Intrelief DN01, SaeboStim One | 2022 | 66 |
| Stimulator, Nerve, Battery-Powered | Class 2 | SunStim Plus Peripheral Nerve Stimulator, SunStim Peripheral Nerve Stimulator, SunStim Pro | 2017 | 2 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | Class 2 | Ultima NEO, IF-4 MultiWave, Ultima Combo, EasySTIM NMS-28 EMS Unit, NerveSpa Pro, TN-28C | 2008 | 32 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | Class 2 | iTENS, SmartTENS, SaeboStim One, Intrelief Combo, Intrelief DN01, EasyStim TN28_OTC and 3 more | 2014 | 57 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Mkiii | GZJ | 1 |
| KGL-1400-F | NUH | 1 |
| PowerTENS | GZJ | 1 |
| IntelliSTIM | IPF | 1 |
| Tens U5 | GZJ | 1 |
| J-stim | NYN | 1 |
| Ultima 20 | GZJ | 1 |
| Ultima 3T+ | GZJ | 1 |
| Ultima Combo | IPF | 1 |
| Activ 8 | IPF | 1 |
| Intrelief Combo | NUH | 1 |
| KGL-1400-M | NUH | 1 |
| LogiSTIM | GZJ | 1 |
| TRi-WAVE | IPF | 1 |
| Ampcare | IPF | 1 |
| iTENS | NUH | 1 |
| Relief Combo | IPF | 1 |
| Intrelief PFE | KPI | 1 |
| TN-20 | NUH | 1 |
| Parasym | GZJ | 1 |
| NDGen | IPF | 1 |
| Ultima NEO | IPF | 1 |
| IntelliSTIM | GZJ | 1 |
| MMI-Micro | GZJ | 1 |
| J Sport Plus | GZJ | 1 |
| MT-11 | GZJ | 1 |
| IF-4 MultiWave | IPF | 1 |
| Tens AA | GZJ | 1 |
Clearances
3 clearances name Easymed Instruments Co., Ltd. as applicant. 5 are held by other companies 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 |
|---|---|---|---|---|
| K241899 | 2024-11-27 | KPI | Traditional | This company |
| K211263 | 2021-12-30 | NUH | Traditional | This company |
| K140168 | 2014-08-28 | NUH | Traditional | This company |
| K153045 | 2016-05-13 | BXN | Special | Easy Med Instrument Co., Ltd. |
| K143430 | 2015-05-29 | NUH | Abbreviated | Easy Med Instrument Co., Ltd. |
| K120054 | 2012-06-05 | GZJ | Abbreviated | Pain Management Technologies |
| K050921 | 2005-12-12 | IPF | Abbreviated | Easy Med Instrument Co., Ltd. |
| K040253 | 2004-04-08 | GZJ | Traditional | Easy Med Instrument Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2002 |
|---|---|
| Main products | TENS/EMS pain relief devices, Pelvic floor rehabilitation devices, Muscle training systems |
| Certifications | ISO 13485, FDA, CE, MDSAP, CFDA, TGA |
| Export markets | Europe, USA, Australia, Canada, Japan, Brazil |
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.