Data / Medical devices / United States / Witko Incorporated
Witko Incorporated: FDA-registered device maker in Wolcott, IN, United States, 1 510(k) clearance
Witko Incorporated is registered with the FDA (registration 3003255790) in Wolcott, IN, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 25, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003255790
- Address
- 9055 W Wolcott Industrial Pkwy, Wolcott, IN, United States, 47995
- Owner or operator
- Witko Incorporated (10044870)
- Roles
- Repackager or relabeler
- First device listed
- August 12, 2013
- Registered through
- 2026
- Brand names listed
- Smart Relief, ThermaCare
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pack, Hot Or Cold, Disposable | IMD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | 2 | Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| July 25, 2013 | K131159 | SMARTRELIEF | NUH | Substantially Equivalent | Chattem, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Pack, Hot Or Cold, Disposable
- All makers of Stimulator, Electrical, Transcutaneous, For Arthritis
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
Updated July 25, 2013. 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.