FDA.reportPublic FDA data

510(k) K810320

Device
HEATPAC
Applicant
SHINSEI CORP.
510(k) number
K810320
Product code
IMB  
Decision
Substantially Equivalent (SESE)
Decision date
1981-03-04
Date received
1981-02-06
Regulation
890.5250
Classification name
Cabinet, Moist Steam
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IMB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K003916DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEMScandia Manufacturing , Ltd.2002-04-15
K955808DYNA T-2000 PHYSICAL THERAPY SYSTEMThermia, Inc.1997-11-03
K914234SAUNETTE, PORTABLE STEAM CABINSauna Magic, Inc.1992-02-11
K770086SANARHealth Improvement Assoc.1977-04-18

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases