Data / Medical devices / United States / Telebrands Corp.
Telebrands Corp.: FDA-registered device maker in Fairfield, NJ, United States, 2 510(k) clearances
Telebrands Corp. is registered with the FDA (registration 2248223) in Fairfield, NJ, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 17, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2248223
- FEI number
- 1000307848
- Address
- 79 Two Bridges RD, Fairfield, NJ, United States, 07004
- Owner or operator
- Telebrands Corporation (10045443)
- Roles
- Complaint file establishment
- First device listed
- July 18, 2014
- Registered through
- 2027
- Brand names listed
- Robin's Egg, XYZ
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laser, Comb, Hair | OAP | 2 | Complaint file establishment | accessdata.fda.gov |
| Orthosis, Lumbar | IQE | 1 | Complaint file establishment | accessdata.fda.gov |
| Orthosis, Truncal/Orthosis, Limb | MRI | 1 | Complaint file establishment | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Complaint file establishment | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| September 17, 2024 | K240689 | Robin's Egg | OAP | Substantially Equivalent | Telebrands Corporation | accessdata.fda.gov |
| April 24, 2014 | K131956 | QUICK RELAX PRO | NUH | Substantially Equivalent | Healthcare Innovations, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Splint, Hand, And Components
- All makers of Laser, Comb, Hair
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Orthosis, Truncal/Orthosis, Limb
- All makers of Orthosis, Lumbar
Updated September 17, 2024. 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.