FDA.reportPublic FDA data

REAL Immersive System

Primary DI
00815948024229
Brand
REAL Immersive System
Company
PENUMBRA, INC.
Model
RLE1-A
Device description
REAL i-Series
Published
2021-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
PWCGeneral Wellness Product

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWCGeneral Wellness ProductUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815948024229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815948024229008159480242298159480242290815948024229

GMDN Terms#

Term, Definition table
TermDefinition
Cognitive training virtual reality softwareA virtual reality software program intended to be used with an off-the-shelf device in conjunction with a virtual reality headset (not included) to help improve a cognitive function (e.g., attention/concentration, reading ability) by providing a patient with an interactive, immersive game; it is not intended for kinesiology-based neuromuscular rehabilitation. It is intended to be used by the patient, at home, school, and in clinical settings in conjunction with clinician consultation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
191077671
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815948025134BenchmarkBMK6F95M-A2023-01-05
00815948025141BenchmarkBMK6F105-A2023-01-05
00815948025158BenchmarkBMK6F105M-A2023-01-05
00815948025165BenchmarkBMK6F115-A2023-01-05
00815948025172BenchmarkBMK6F115M-A2023-01-05
00815948025189BenchmarkBMK6F95BER120-A2023-01-05
00815948025196BenchmarkBMK6F95SIM120-A2023-01-05
00815948025202BenchmarkBMK6F95MBER120-A2023-01-05
00815948025219BenchmarkBMK6F95MSIM120-A2023-01-05
00815948025226BenchmarkBMK6F105BER130-A2023-01-05
00815948025233BenchmarkBMK6F105SIM130-A2023-01-05
00815948025240BenchmarkBMK6F105MBER130-A2023-01-05
00815948025257BenchmarkBMK6F105MSIM130-A2023-01-05
00815948022553Indigo SystemLITNG12HTORQ100-A2020-07-15
00815948022560Indigo SystemLITNG12XTORQ100-A2020-07-15
00815948022577Indigo SystemLITNG12HTORQ115-A2020-07-15
00815948022591Indigo SystemLITNG12XTORQ115-A2020-07-15
00815948022904Indigo SystemLITNG12HTORQ1002020-07-15
00815948022911Indigo SystemLITNG12XTORQ1002020-07-15
00815948022928Indigo SystemLITNG12HTORQ1152020-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978959250040Bed Wedge Pillow (7 inch)Xiamen SeaWorld Houseware Co., Ltd.PWC2025-07-31
06978959250057Big Wedge PillowXiamen SeaWorld Houseware Co., Ltd.PWC2025-07-31
06978959250118Leg Elevation Pillow (CoolingGel)Xiamen SeaWorld Houseware Co., Ltd.PWC2025-07-31
15060498452189Motion Medical DistributingHaslam Medical, Inc.PWC2022-12-29
B3437000A3POLY ProMedtek Lighting CorporationPWC2018-10-31
B3437000C1Poly GoMedtek Lighting CorporationPWC2017-09-01
B3437000C21Poly SpotMedtek Lighting CorporationPWC2017-09-01