Data / Medical devices / United States / Truerelief
Truerelief: FDA-registered device maker in Scottsdale, AZ, United States, 2 510(k) clearances
Truerelief is registered with the FDA (registration 3015550326) in Scottsdale, AZ, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated March 23, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015550326
- Address
- 9375 E Shea Blvd Ste 250c, Scottsdale, AZ, United States, 85260
- Owner or operator
- TrueRelief (10060510)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- May 20, 2019
- Registered through
- 2026
- Brand names listed
- TRUERELIEF Kit, Model TR1250C TRUERELIEF Kit, TRUERELIEF Power Cord with Wall Wart, Model WW12 Power Cord with Wall Wart, TRUERELIEF Primary Probe, Model P12P Primary Probe, TRUERELIEF Probe Tips, Probe Tips, Model P12T10 Probe Tips, TRUERELIEF Secondary Probe, Model P12S Secondary Probe, TRUERELIEF, Model 1250 TRUERELIEF Device, TRUERELIEF 1250, TrueRellief Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Complaint file establishment, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| March 23, 2021 | K202186 | TrueRelief Device | GZJ | Substantially Equivalent | Truerelief | accessdata.fda.gov |
| April 25, 2007 | K070474 | NEWLIFE SCIENCES LLC, MODEL TMR | GZJ | Substantially Equivalent | Newlife Sciences, LLC | accessdata.fda.gov |
Compare with other makers
Updated March 23, 2021. 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.