FDA.reportPublic FDA data

BUG

Primary DI
08055715702949
Brand
BUG
Company
ORMESA SRL
Model
BUG SMALL 869 NARROW BASE (black), LIGHT GREY GREE
Device description
Postural sitting unit intended for children with disabilities (Infantile Cerebral Palsy, degenerative pathologies with functional impairments, syndromic pathologies with impairments functional) easily adaptable thanks to its modularity. Suitable for users who have little or no control of the trunk and head and needing appropriate stabilization a pelvic level to be able to assume, in situations where residual functionality allows it, the more appropriate posture in different everyday contexts, both internally and externally.
Published
2026-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
08055715702949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055715702949080557157029498055715702949

GMDN Terms#

Term, Definition table
TermDefinition
Assistive pushchairA wheeled mobility device manually propelled by an attendant that consists of a open framework with one or more handle(s) designed to carry one or more person(s) with a disability in a seated or semi-lying (semi-recumbent) position.

Regulatory Flags#

DUNS number
432070019
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08054040401879BIKOBIKO MINI ROSSO SWITCH LIB./FISSO2026-08-01
08054040401886BIKOBIKO MINI ROSA SWITCH LIB./FISSO2026-08-01
08054040401893BIKOBIKO SMALL BLU DIFFERENZ.SWITCH2026-08-01
08054040401909BIKOBIKO SMALL ROSSO DIFFERENZ.SWITCH2026-08-01
08054040401916BIKOBIKO SMALL ROSA DIFFERENZ.SWITCH2026-08-01
08054040401923BIKOBIKO MEDIUM BLU DIFFERENZ.SWITCH2026-08-01
08054040401930BIKOBIKO MEDIUM ROSSO DIFFERENZ.SWITCH2026-08-01
08054040401947BIKOBIKO MEDIUM VERDE DIFFERENZ.SWITCH2026-08-01
08054040401954BIKOBIKO LARGE BLU DIFFERENZ.SWITCH2026-08-01
08054040401961BIKOBIKO LARGE ROSSO DIFFERENZ.SWITCH2026-08-01
08054040401978BIKOBIKO LARGE VERDE DIFFERENZ.SWITCH2026-08-01
08054040401985BIKOBIKO XL BLU DIFFERENZ.SWITCH2026-08-01
08054040401992BIKOBIKO XL ROSSO DIFFERENZ.SWITCH2026-08-01
08054040402005BIKOBIKO XL VERDE DIFFERENZ.SWITCH2026-08-01
08054040402135BUGBUG-S UNITA'SED.SENZA TAPPEZZER.192026-08-01
08054040402142BUGBUG-M UNITA'SED.SENZA TAPPEZZER.192026-08-01
08054040402548GRILLOGRILLO SMALL ANT.PT(PELV./MINI)IBR2026-08-01
08054040402876BIKOBIKO SMALL ROSSO RUOTA LIBERA2026-08-01
08054040403729BIKOBIKO XL BLU 864 DIFF.RUOTA LIBERA SU MISURA2026-08-01
08055715702956BUGBUG SMALL 869 NARROW BASE (black), DARK GREY GREEN2026-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08054040402135BUGORMESA SRLINM2026-08-01
08054040402142BUGORMESA SRLINM2026-08-01
08055715702956BUGORMESA SRLINM2026-08-01
08055715702963BUGORMESA SRLINM2026-08-01
08055715702970BUGORMESA SRLINM2026-08-01
08055715703021BUGORMESA SRLINM2026-08-01
08055715703038BUGORMESA SRLINM2026-08-01
08055715703045BUGORMESA SRLINM2026-08-01
08055715703052BUGORMESA SRLINM2026-08-01
08055715703106BUGORMESA SRLINM2026-08-01
08055715703113BUGORMESA SRLINM2026-08-01
08055715703120BUGORMESA SRLINM2026-08-01
08055715703137BUGORMESA SRLINM2026-08-01
08055715703182BUGORMESA SRLINM2026-08-01
08055715703199BUGORMESA SRLINM2026-08-01
08055715703205BUGORMESA SRLINM2026-08-01
08055715703212BUGORMESA SRLINM2026-08-01
06973717271602GARVEEFoshan Dahao Medical Technology Co., Ltd.INM2026-07-29
06973717271633GARVEEFoshan Dahao Medical Technology Co., Ltd.INM2026-07-29
06973717272104GARVEEFoshan Dahao Medical Technology Co., Ltd.INM2026-07-29
06973717276836GARVEEFoshan Dahao Medical Technology Co., Ltd.INM2026-07-29
06973717276843GARVEEFoshan Dahao Medical Technology Co., Ltd.INM2026-07-29
06973717276881GARVEEFoshan Dahao Medical Technology Co., Ltd.INM2026-07-29
06973717276829VerpalFoshan Dahao Medical Technology Co., Ltd.INM2026-06-06
00840117408739ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408746ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408753ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408760ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408777ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408784ConvaidCONVAID PRODUCTS, INC.INM2026-04-10