Sana

Primary DI
00850039306068
Brand
Sana
Company
Sana Health, Inc.
Model
Beta MK4
Catalog number
Beta MK4
Device description
Audio-visual stimulator for pain relief. The Sana device is a mask that is worn on your face, similar to a transitional sleep mask. The Sana device delivers gentle coordinated pulses of light (through closed eyelids) and sound (through headphones) that encourage a natural relaxation state and temporarily reduces neuropathic pain. This device is intended to be used adjunctively to other modes of therapy to relieve pain.
Published
2026-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
QYNPrescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QYNPrescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)Physical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850039306068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850039306068008500393060688500393060680850039306068

GMDN Terms#

Term, Definition table
TermDefinition
Pain relief virtual reality systemAn electrically-powered virtual reality (VR) device assembly intended to help relieve chronic pain (e.g., back pain, osteoarthritis) by providing a patient with immersive visual techniques and distractions to self-manage pain (e.g., breathing techniques, interactive games, mindfulness, cognitive behavioural therapy), sometimes with supplemental educational information. It consists of a headset with user interface and controls, and preinstalled VR software. It is intended to be used by a patient at home under clinician consultation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth0
Height0
Weight0
Width0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
(720) 310-3370support@sana.io

Regulatory Flags#

DUNS number
080810418
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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