Devon Medical Products (Jiangsu) Ltd
Registered establishment in Nantong, Jiangsu, China. 12 device types, 6 clearances.
Devon Medical Products (Jiangsu) Ltd is a repacker / relabeller holding a current FDA establishment registration. The registration covers Pad, Heating, Powered, Sleeve, Limb, Compressible and 10 other device types. Its earliest product listing with the FDA dates from 2016.
Registration
| Registered name | DEVON MEDICAL PRODUCTS (JIANGSU) LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009538657 |
| FEI number | 3009538657 |
| Establishment type | Repacker / relabeller, Manufacturer |
Location
| City | Nantong |
|---|---|
| Province | Jiangsu |
| Address | No.8 Tongxing Road,Economic & Technological Development Area |
| Postal code | 226009 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Joint, Knee, External Brace | Class 1 | Compression Socks | 2026 | 137 |
| Negative Pressure Wound Therapy Powered Suction Pump | Class 2 | negative pressure wound therapy foot dressing, negative pressure wound therapy Powered suction pump, Gel Strip, Negative pressure wound therapy canisters, Foam Kit | 2016 | 8 |
| Pad, Heating, Powered | Class 2 | muscle conditioning | 2021 | 144 |
| Sleeve, Limb, Compressible | Class 2 | Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System, Sequential Compression Device, Devon 62, Devon 24D, Devon 52 | 2016 | 24 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | Class 2 | muscle conditioning | 2021 | 22 |
| Stimulator, Muscle, Powered | Class 2 | muscle conditioning | 2021 | 33 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | Class 2 | muscle conditioning | 2021 | 66 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | Class 2 | muscle conditioning | 2021 | 32 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | Class 2 | muscle conditioning | 2021 | 57 |
| Stimulator, Neuromuscular, External Functional | Class 2 | muscle conditioning | 2021 | 8 |
| Stocking, Medical Support (For General Medical Purposes) | Class 1 | Compression Socks | 2026 | 76 |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | Class 2 | Compression Socks | 2026 | 21 |
Clearances
6 clearances name Devon Medical Products (Jiangsu) Ltd as applicant. 9 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 |
|---|---|---|---|---|
| K190423 | 2019-03-19 | JOW | Special | This company |
| K182578 | 2019-02-21 | JOW | Traditional | This company |
| K182150 | 2018-12-18 | JOW | Special | This company |
| K173528 | 2018-02-06 | JOW | Special | This company |
| K172030 | 2017-11-27 | JOW | Traditional | This company |
| K170814 | 2017-07-11 | JOW | Traditional | This company |
| K182203 | 2019-03-14 | NUH | Traditional | Jkh USA, LLC |
| K151240 | 2015-06-09 | OMP | Special | Devon Medical Products |
| K143362 | 2015-02-03 | OMP | Special | Devon Medical Products |
| K140634 | 2014-09-19 | OMP | Traditional | Devon Medical, Inc. |
| K141578 | 2014-06-27 | JOW | Traditional | Devon Medical, Inc. |
| K132225 | 2014-05-15 | OMP | Traditional | Devon Medical, Inc. |
| K132252 | 2013-09-27 | OMP | Special | Devon Medical, Inc. |
| K131464 | 2013-08-13 | OMP | Special | Devon Medical, Inc. |
| K110078 | 2012-02-10 | OMP | Traditional | Devon Medical Products |
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.