Data / Medical devices / United States / Electrostim Medical Services, Inc.
Electrostim Medical Services, Inc.: FDA-registered device maker in Tampa, FL, United States, 6 510(k) clearances
Electrostim Medical Services, Inc. is registered with the FDA (registration 3003573572) in Tampa, FL, United States. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 21, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003573572
- Address
- 3504 Cragmont Dr Ste 100, Tampa, FL, United States, 33619
- Owner or operator
- EMSI (9049301)
- Roles
- Specification developer
- First device listed
- April 1, 2008
- Registered through
- 2026
- Brand names listed
- Conductive Glove, Conductive Sleeve, Conductive Sock, Flex-Gar Glove, Flex-Gar Sleeve, Flex-Gar Sock, Flex-IT, Flex-MI and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Specification developer | accessdata.fda.gov |
| Interferential Current Therapy | LIH | 2 | Specification developer | accessdata.fda.gov |
| Joint, Knee, External Brace | ITQ | 1 | Specification developer | accessdata.fda.gov |
| Orthosis, Lumbo-Sacral | IPY | 1 | Specification developer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Specification developer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | 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 |
|---|---|---|---|---|---|---|
| October 21, 2022 | K221958 | Flex-MI | IPF | Substantially Equivalent | Emsi, Inc. | accessdata.fda.gov |
| October 7, 2014 | K140467 | FLEX-MT + | IPF | Substantially Equivalent | Emsi | accessdata.fda.gov |
| December 4, 2009 | K090889 | EMSI GARMENT ELECTRODES | GXY | Substantially Equivalent | Emsi | accessdata.fda.gov |
| May 8, 2009 | K090717 | FLEX-TENS | GZJ | Substantially Equivalent | Emsi | accessdata.fda.gov |
| February 5, 2009 | K083030 | TENS-EMS-14 | GZJ | Substantially Equivalent | Emsi | accessdata.fda.gov |
| March 7, 2008 | K071869 | TENS/IF 14 | GZJ | Substantially Equivalent | Emsi | accessdata.fda.gov |
Compare with other makers
- All makers of Interferential Current Therapy
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Joint, Knee, External Brace
- All makers of Stimulator, Muscle, Powered
- All makers of Orthosis, Lumbo-Sacral
- All makers of Electrode, Cutaneous
Updated October 21, 2022. 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.