Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1063324

FEI Number

3003382542

Entity Name

REACT Innovations

City/State/Country

Charlotte, NC, US

Establishment Address

542 W 32nd St, Charlotte, NC 28206, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

React Innovations (Owner Number: 10055784)

Owner / Operator Contact Address

1809 Browning Ave., Charlotte, NC 28205, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K973096

PMA Number

N/A

All Registered Proprietary Names

REACT Table Pelvic Wave React Table Pelvic Wave

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2025-09-22
FRK	Chair, Examination And Treatment	General Hospital	Class 1	880.6140	2025-09-22
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2017-10-06
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2017-10-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

React Innovations

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17
K231440	Shenzhen Roundwhale Technology Co. , Ltd.	Combo Electrotherapy Device	2023-11-03
K820884	Nitron Electronics	ELECTRICAL MUSCLE STIMULATOR	1982-04-29
K201958	Therasigma, LLC	ETD Family of Electrotherapy Devices	2020-08-04
K964028	Mettler Electronics Corp.	SYS STIM 226	1997-02-03

Similar Registrations

Registration Number	Establishment Name	Location
9615415	PRIME PACIFIC HEALTH INNOVATIONS CORPORATION	PORT COQUITLAM British Columbia, CA
2242467	HAUSMANN ENTERPRISES, LLC	NORTHVALE, NJ, US
3043460907	Drive DeVilbiss Healthcare	Perris, CA, US
3005214422	HOMECARE ENTERPRISE CO., LTD.	Changhua City, TW
3008533516	Intensa, Inc.	High Point, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1063324. Last updated year: 2026. Please use registration number 1063324 when referencing this establishment in official correspondence.