FDA.reportPublic FDA data

510(k) K925247

Device
STONEHEART ROLLER AID
Applicant
STONEHEART, INC.
510(k) number
K925247
Product code
INM  
Decision
Substantially Equivalent (SESE)
Decision date
1993-02-12
Date received
1992-10-16
Regulation
890.3100
Classification name
Chair, With Casters
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
HEATHER STONE
Address
224 2nd St., Box 329 Cheney WA US 99004 99004

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code INM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K063521NISSIN PEDIATRIC SERIES WHEELCHAIRNissin Medical, Inc.2007-02-05
K941738STRYKER 5050 STRECHAIRStryker Medical1994-05-06
K941569CAREMOR CLINERWinco, Inc.1994-04-26
K933000RECLINING GERI CHAIRS W/CASTERS & LAP TRAYWinco, Inc.1993-09-30
K926028BENCHESTheradapt Products, Inc.1993-03-24
K926025CHAIRSTheradapt Products, Inc.1993-03-22
K926053ELD-ARONDAK CHAIRAlert Care, Inc.1993-03-22
K926054ELD-ARONDAK CHAIRAl'S Woodcraft, Inc.1993-03-22
K924848KAYE SCOOT-ABOUT, MODEL SB1Kaye Products, Inc.1993-02-12
K921917DOLOMITE ROLLATORSeamark Technologies1992-05-26
K922045SHOWER CHAIRSMedical Device Inspection Co., Inc.1992-05-26
K921752AMBULATORThe Anthros Medical Group1992-05-04
K921817RIFTON MOR219 19 & RIFTON MOR225 25Rifton Equipment For the Handicapped1992-04-29
K913544DUKKIPin Dot Products, Inc.1991-08-29
K895165ZIGGY MEDICHAIRLaszlo Corp.1989-09-11

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