Danyang Rapid Aid Hot and Cold Therapy Products Co., Ltd.
Registered establishment in Danyang, Jiangsu, China. 6 device types.
Danyang Rapid Aid Hot and Cold Therapy Products Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Bag, Ice, Accessory, Surgical Apparel and 4 other device types. Its earliest product listing with the FDA dates from 2008.
Registration
| Registered name | Danyang Rapid Aid Hot and Cold Therapy Products Co. Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008955719 |
| FEI number | 3008955719 |
| Establishment type | Contract manufacturer, Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
Location
| City | Danyang |
|---|---|
| Province | Jiangsu |
| Address | Glasses Industrial Park, Danfu Road |
| Postal code | 212300 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Rapid Aid Face Shield | 2020 | 439 |
| Adhesive Backed Thermal Skin Patches | Class 1 | Adhesive backed thermal skin patches | 2024 | 48 |
| Bag, Ice | Class 1 | Ice Bag | 2020 | 86 |
| Infant Heel Warmer (Chemical Heat Pack) | Class 1 | Infant Heel Warmer, with Disc, Infant Heel Warmer | 2008 | 2 |
| Pack, Hot Or Cold, Disposable | Class 1 | Infant Transport Mattress Warmer, Instant Warm Perineal Pack with self- adhesive strip, Instant Cold Pack, Instant Hot Pack, Instant Cold Pack with self- adhering wrap, Instant Warm Pack and 4 more | 2008 | 176 |
| Pack, Hot Or Cold, Reusable | Class 1 | Calf/Shin Pack, Achilles Pack, Plantar Pack, Reusable Cold Gel Pack, Cold Slipper, Reusable Hot & Cold Compress Wrap and 6 more | 2008 | 178 |
Clearances
No clearance names Danyang Rapid Aid Hot and Cold Therapy Products Co., Ltd. as applicant. 3 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 |
|---|---|---|---|---|
| K163295 | 2017-07-24 | IMD | Traditional | Rapid AID Corp. |
| K150627 | 2015-05-27 | MPO | Special | Rapid AID Corp. |
| K040856 | 2004-05-03 | MPO | Traditional | Rapid AID Corp. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2010 |
|---|---|
| Main products | Hot and cold therapy packs, Gel packs, Reusable hot/cold compress, Instant hot and cold packs |
| Certifications | FDA, ISO 13485 |
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.