Data / Medical devices / United States / Prizm Medical, Inc.
Prizm Medical, Inc.: FDA-registered device maker in Buford, GA, United States, 7 510(k) clearances
Prizm Medical, Inc. is registered with the FDA (registration 1055808) in Buford, GA, United States. It lists 6 device types. The FDA files 7 510(k) clearances under its listings, the newest dated December 3, 2014. 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
- 1055808
- FEI number
- 1000110974
- Address
- 5153 Belle Wood Ct Ste E, Buford, GA, United States, 30518
- Owner or operator
- PRIZM MEDICAL, INC. (9005746)
- Roles
- Contract manufacturer, Contract sterilizer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 12, 2006
- Registered through
- 2026
- Brand names listed
- E-GLOVE, E-SOCK, E-STOCKING, E-SLEEVE, E-GLOVE, E-STOCKING, E-SLEEVE, E-SOCK, ELECTRO-MESH: GLOVE, SOCK, SLEEVE, WRAP & PANELS, MICRO-Z STIMULATION SYSTEM, Micro-Z II, Micro-Z Mini, Model #15045, Model #15053 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Media, Electroconductive | GYB | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Contract manufacturer, Contract sterilizer, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | 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 |
|---|---|---|---|---|---|---|
| December 3, 2014 | K133502 | 5000Z FIREFLY SYSTEM | NUH | Substantially Equivalent | Prizm Medical, Inc. | accessdata.fda.gov |
| August 25, 2004 | K033122 | 5000Z SYSTEM (OTC) | NUH | Unknown | Prizm Medical, Inc. | accessdata.fda.gov |
| July 30, 2004 | K032239 | THERA-CREAM, MODEL TCT004 | GYB | Substantially Equivalent | Prizm Medical, Inc. | accessdata.fda.gov |
| July 23, 2002 | K012974 | PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007 | FLL | Substantially Equivalent | Prizm Medical, Inc. | accessdata.fda.gov |
| November 21, 1995 | K951727 | Z-WATCH SYSTEM | IPF | Substantially Equivalent for Some Indications | Prizm Medical, Inc. | accessdata.fda.gov |
| February 21, 1995 | K944487 | ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODES | GXY | Substantially Equivalent | Prizm Medical, Inc. | accessdata.fda.gov |
| July 1, 1994 | K932299 | ELECTRO-MESH | GXY | Substantially Equivalent | Prizm Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Cutaneous
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Stimulator, Muscle, Powered
- All makers of Continuous Measurement Thermometer
- All makers of Media, Electroconductive
Updated December 3, 2014. 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.