Data / Medical devices / United States / Pain Care Labs
Pain Care Labs: FDA-registered device maker in Atlanta, GA, United States, 2 510(k) clearances
Pain Care Labs is registered with the FDA (registration 3007439125) in Atlanta, GA, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 15, 2023. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3007439125
- Address
- 195 Arizona Ave LW08, Atlanta, GA, United States, 30307
- Owner or operator
- MMJ Labs dba Pain Care Labs (10027555)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- August 18, 2014
- Registered through
- 2026
- Brand names listed
- BUZZY®, Buzzy(R) Ice Wings, Buzzy®, Buzzy® Healthcare, Buzzy® LadyBuzz, Buzzy® Mini Healthcare, Buzzy® Mini Personal, Buzzy® Pro and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cold Pack And Vibrating Massager | PHW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| May 15, 2023 | K202993 | Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H) | PHW | Substantially Equivalent | Mmj Labs, LLC | accessdata.fda.gov |
| August 13, 2014 | K130631 | BUZZY | PHW | Substantially Equivalent | Mmj Labs, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Cold Pack And Vibrating Massager
- All makers of Pack, Hot Or Cold, Reusable
- All makers of Pack, Hot Or Cold, Disposable
- All makers of Massager, Therapeutic, Electric
- All makers of Tourniquet, Nonpneumatic
Updated May 15, 2023. 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.