FDA.reportPublic FDA data

ARIA

Primary DI
00885556803868
Brand
ARIA
Company
Smith & Nephew, Inc.
Model
SSK1
Catalog number
SSK1
Device description
ARIA HOME PT SOFTWARE
Published
2021-04-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXJInteractive Rehabilitation Exercise Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXJInteractive Rehabilitation Exercise DevicesPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192474000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192474000VERAReflexion Health, Inc.2019-10-10LXJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556803868PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556803868008855568038688855568038680885556803868

GMDN Terms#

Term, Definition table
TermDefinition
Virtual-display rehabilitation system, non-supportive, clinicalAn assembly of devices intended to be used in a clinical setting to provide non-gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the back/trunk/limbs (e.g., impaired limb function) through patient interaction with a videogame-like display prompting repeated motion of a body part (e.g., arm, hand, leg) for functional improvement (e.g., reaching, grasping, balance); it may also provide performance feedback. It does not provide weight support and is based on motion-sensing devices [e.g., battery-powered patient-worn infrared (IR) glove, movement tracking camera, software) that communicate wirelessly to provide a virtual-display interface.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010482280CLEAR-TRAC721012172101212015-10-22
03596010532619NA721071972107192015-08-30
03596010505132SCULPTOR721069772106972015-08-30
03596010505149SCULPTOR721069672106962015-08-30
03596010505170SCULPTOR721069572106952015-08-30
03596010505194SCULPTOR721070072107002015-08-30
00885554016703560P72202351722023512015-08-29
00885556919781Real IntelligenceROB30007ROB300072026-10-13
00885556924327Real IntelligenceROB30801ROB308012026-10-08
03596010445803NA720903072090302015-08-30
03596010470294SAPHYRE720968472096842015-08-30
03596010470331ABLATOR720965972096592015-08-30
03596010470348ABLATOR720965872096582015-08-30
03596010470416ABLATOR720965172096512015-08-30
03596010470577ABLATOR720965072096502015-08-30
03596010470614TAC-S720963272096322015-08-30
03596010448446TWINFIX720910972091092015-08-30
03596010470393ABLATOR720965372096532015-08-30
03596010470423ABLATOR720964972096492015-08-30
03596010510976NA721004072100402015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199874027012JintronixLudica Health Inc.LXJ2026-04-20
B179SEVBUN050SMARTBTS SPALXJ2024-12-27
B179SEVBUN090SMARTBTS SPALXJ2024-12-27
B179SEVBUN260SMARTBTS SPALXJ2024-12-27
B179SEVBUN020SMARTBTS SPALXJ2024-12-20
B179SDXEVO1SMARTBTS SPALXJ2023-09-06
00627843933236KneeKG systemEmovi IncLXJ2022-03-23
07300009074518Qualisys Clinical SystemQualisys ABLXJ2020-09-02
00860001498400VERAREFLEXION HEALTH, INC.LXJ2019-06-30
05707480042548Sleepmate / SparepartBody Position BandAmbu A/SLXJ2019-01-10
05707480042661Body Position Sensor - Alice 3Ambu A/SLXJ2019-01-07
05707480042777VIASYS QDC CABLE GREENAmbu A/SLXJ2019-01-07
05707480042807VIASYS QDC CABLE BROWNAmbu A/SLXJ2019-01-07
05707480042272SleepmateAC Body Position Sensor KitAmbu A/SLXJ2019-01-03
05707480042500SleepmateDC Low Impedance KitAmbu A/SLXJ2019-01-03
05707480042555SleepmateAC Body Position SensorAmbu A/SLXJ2019-01-03
05707480042609SleepmateDC Body Position Sensor - ViasysAmbu A/SLXJ2019-01-03
05707480042685SleepmateDC Body Position Sensor - CadwellAmbu A/SLXJ2019-01-03
05707480042715SleepmateBody Position Sensor - Alice 5Ambu A/SLXJ2019-01-03
05707480042838SleepmateBody Position - CadwellAmbu A/SLXJ2019-01-03
05707480043477SleepmateBody Position SensorAmbu A/SLXJ2019-01-03
03760272650019MindMotion™ GONeuroXtherapeutics SALXJ2018-05-28
03760272650002MindMotion PRONeuroXtherapeutics SALXJ2017-08-01
00863090000400SaeboVRVIRTUAL THERAPY SOLUTIONS, LLC.LXJ2017-06-01
B548BONITASYSTEM0VICONVICON MOTION SYSTEMS LIMITEDLXJ2017-04-18
B548VICONTSERIESSYSTEM0VICONVICON MOTION SYSTEMS LIMITEDLXJ2017-04-18
B548VICONVANTAGESYSTEM0VICONVICON MOTION SYSTEMS LIMITEDLXJ2017-04-18
B548VICONVEROSYSTEM0VICONVICON MOTION SYSTEMS LIMITEDLXJ2017-04-18
B179SDXSMARTBTS SPALXJ2017-02-12