Data / Medical devices / United States / REACT Innovations
REACT Innovations: FDA-registered device maker in Charlotte, NC, United States, 2 510(k) clearances
REACT Innovations is registered with the FDA (registration 1063324) in Charlotte, NC, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 12, 1998. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1063324
- FEI number
- 3003382542
- Address
- 542 W 32nd St, Charlotte, NC, United States, 28206
- Owner or operator
- React Innovations (10055784)
- Roles
- Manufacturer
- First device listed
- October 6, 2017
- Registered through
- 2026
- Brand names listed
- Pelvic Wave, REACT Table, React Table
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chair And Table, Medical | KMN | 1 | Manufacturer | accessdata.fda.gov |
| Chair, Examination And Treatment | FRK | 1 | Manufacturer | accessdata.fda.gov |
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 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 |
|---|---|---|---|---|---|---|
| June 12, 1998 | K973096 | NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM | KPI | Substantially Equivalent | Neotonus, Inc. | accessdata.fda.gov |
| May 21, 1998 | K973929 | NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM | IPF | Substantially Equivalent | Neotonus, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Muscle, Powered
- All makers of Stimulator, Electrical, Non-Implantable, For Incontinence
- All makers of Chair And Table, Medical
- All makers of Chair, Examination And Treatment
Updated June 12, 1998. 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.