FDA.reportPublic FDA data

INTENSA

Primary DI
M368IN587WDALPA1
Brand
INTENSA
Company
GF HEALTH PRODUCTS, INC.
Model
IN587WDALPA
Device description
RECL WIDE DRP ARMS ALABASTER
Published
2024-02-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
INMChair, With Casters

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INMChair, With CastersPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M368IN587WDALPA1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Reclining chairA manually-operated, general-purpose device designed to support a patient in a seated position; it includes a back rest that reclines for patient comfort. The chair is intended to be used in a variety of settings including recovery from minor procedures, during convalescence, while donating blood, or while receiving chemotherapy. It may have a height-adjustable mechanism and have attached armrests, footrests, and/or legrests.

Contacts#

Phone, Email table
PhoneEmail
7703684700cs@grahamfield.com

Regulatory Flags#

DUNS number
132016168
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M36811331LUMISCOPE11332016-08-31
M36832141Grafco321432142021-06-09
M368EPC500ST1HAUSTEDEPC500ST2026-04-09
M368EPC500STMB1HAUSTEDEPC500ST-MB2026-04-09
M3681097001GRAHAM FIELD109-7002026-02-20
M36812731Grafco127312732020-10-01
M36812751Grafco127512752020-10-01
M3684001GF1GRAFCO4001GF4001GF2020-04-01
M3684002GF1GRAFCO4002GF4002GF2020-04-01
M3682362X1GRAHAM FIELD2362X2026-02-20
M3681097002GRAHAM FIELD109-7002026-02-20
M3682338A1GRAHAM FIELD2338A 2026-02-20
M3682338X1GRAHAM FIELD2338X2026-02-20
M36823452A1GRAHAM FIELD2345-2A2026-02-20
M36823452C1GRAHAM FIELD2345-2C 2026-02-20
M36823452X1GRAHAM FIELD2345-2X2026-02-20
M36823481A1GRAHAM FIELD2348-1A 2026-02-20
M36823552N1GRAHAM FIELD2355-2N 2026-02-20
M36823552X1GRAHAM FIELD2355-2X 2026-02-20
M36823562A1GRAHAM FIELD2356-2A 2026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08054040400612ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400629ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400636ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400643ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400650ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400667ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402074ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402081ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402098ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402104ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402111ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402128ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402210ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402227ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402234ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402241ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402258ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402265ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402272ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402289ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402296ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402302ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402319ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402326ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402333ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402340ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402357ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402364ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402371ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402388ADJUSTABLE TROLLIORMESA SRLINM2026-09-06