Data / Medical devices / Taiwan / Ten Comfort Corp.
Ten Comfort Corp.: FDA-registered device maker in New Taipei City, Taiwan, 3 510(k) clearances
Ten Comfort Corp. is registered with the FDA (registration 9616309) in New Taipei City, Taiwan. It lists 8 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 22, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9616309
- FEI number
- 3003750857
- Address
- 6F-3, No. 213, Fu-Ho Road Yung-Ho District, New Taipei City, Taiwan, 23450
- Owner or operator
- TEN COMFORT CORP. (9038541)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- January 8, 2001
- Registered through
- 2026
- Brand names listed
- Battery-Powered Transilluminator, Disposable Scope Warmer, Clear Scope Kit, HOT PACK COMPRESS, HOTPAD, Infant Heel Warmer, PURECARE AT-903 TENS, Presurgical Hot / Cold Pad, TEN COMFORT COLD and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Infant Heel Warmer (Chemical Heat Pack) | MPO | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Laparoscopic Accessories, Gynecologic | NWV | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Water Circulating | ILO | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Transilluminator, Battery-Powered | HJN | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 22, 2003 | K032989 | MEDI-HEAT INFANT HEEL WARMER | MPO | Substantially Equivalent | Mediheat, Inc. | accessdata.fda.gov |
| January 27, 1994 | K931715 | PURECARE AT-903 T.E.N.S. | GZJ | Substantially Equivalent | Fuching Enterprise Co., Ltd. | accessdata.fda.gov |
| February 12, 1993 | K915876 | HOTPAD | IME | Substantially Equivalent | Ten Comfort Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Pack, Hot Or Cold, Reusable
- All makers of Massager, Therapeutic, Electric
- All makers of Transilluminator, Battery-Powered
- All makers of Pack, Hot Or Cold, Water Circulating
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Laparoscopic Accessories, Gynecologic
Updated October 22, 2003. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.