Regulatory Insight, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Regulatory Insight, Inc. makes
Regulatory Insight, Inc. manufactures manual mechanical wheelchairs, including models like the SL 803, SL 804, and EN 600-series variants, as well as the ETHEREA model. The company also produces pelvic floor training devices, such as the Kegel Smart and KegelSmart Pearl.
These products are classified as Class I or Class II medical devices under FDA regulations and are recorded in the FDA’s 510(k) clearance database. The company is based in the United States.
Catalogue
Sl 803, Sl 804, Sl 807, Sl 809, Sl 506, Sl 501, Sl 805 And Sl 801 Mechanical Wheelchairs Ref K020100
Regimes: 510(k) Registry: 510(k)Etherea Ref K112505
Regimes: 510(k) Registry: 510(k)Kegel Smart, Kegelsmart Pearl Ref K140780
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Regulatory Insight, Inc., initiated on 2008-07-01. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2008
- 1 Jul 2008 Z-0753-2016 Class II Terminated It was discovered that the Remote Touch Panel (RTP) of the GE Precision MPi X-ray system may not always boot up as intended and needs to be updated to properly accomplish its intended purpose.
Frequently asked questions
How many devices does Regulatory Insight, Inc. have in the registry?
The registry currently lists 4 devices for Regulatory Insight, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Regulatory Insight, Inc.'s devices?
Among its 4 most recently registered devices, Regulatory Insight, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Regulatory Insight, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Regulatory Insight, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Regulatory Insight, Inc.?
FDA recall records list 1 recall initiated by Regulatory Insight, Inc., the most recent initiated on 1 Jul 2008. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Regulatory Insight, Inc. in the registry?
The most recently registered devices listed for Regulatory Insight, Inc. include SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRS, ETHEREA, KEGEL SMART, KEGELSMART PEARL and EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-665 AND EN 600-670 MECHANICAL WHEELCHAIRS.