FDA.reportPublic FDA data

Therabody

Primary DI
00840295400440
Brand
Therabody
Company
Therabody, Inc.
Model
SmartGoggles
Published
2022-08-03
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
PGJOximeter, Wellness

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGJOximeter, WellnessCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840295400440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840295400440008402954004408402954004400840295400440

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeterAn electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080550811
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840295411637TherabodyCryoTherm Palm2026-06-01
00840295405391Therabody TheraFace Depuffing Wand2024-06-16
00840295401782Therabody RecoveryTherm Cube2023-11-07
00840295401874Therabody Theragun PRO PLUS2023-11-07
00810036059732TherabodyRecoveryTherm Hot/Cold/Vibration Knee 2022-06-06
00810036056762TheraFaceTheraFace Hot & Cold Rings Black2022-01-18
00810036056809TheraFaceTheraFace Hot & Cold Rings White2022-01-18
00840295408224TherabodyTheraFace Conductive Gel2025-01-26
00840295405568TherabodyJetBoots PRO Plus Short2024-11-08
00840295405575TherabodyJetBoots PRO Plus Regular2024-11-08
00840295405582TherabodyJetBoots PRO Plus Long2024-11-08
00840295405698TherabodyJetBoots Prime Small2024-07-17
00840295405704TherabodyJetBoots Prime Medium2024-07-17
00840295405711TherabodyJetBoots Prime Large2024-07-17
00810036056687TheraFaceTheraFace PRO White2022-01-18
00810036056724TheraFaceTheraFace PRO Black2022-01-18
00810036056229RecoveryAir RecoveryAir JetBoots Small2021-12-23
00810036056908RecoveryAirRecoveryAir JetBoots Medium2021-12-23
00810036056946RecoveryAirRecoveryAir JetBoots Large2021-12-23
00810036056984RecoveryAirRecoveryAir Prime Pump2021-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00050428167335CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDPGJ2026-07-10
00050428167342CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDPGJ2026-07-10
00850022853067ProSomnus HWO2 DevicePROSOMNUS SLEEP TECHNOLOGIESPGJ2026-04-24
06938395500291HomedicsShenzhen Hexin ZONDAN Medical Equipment Co., LtdPGJ2026-04-22
06938395500307HomedicsShenzhen Hexin ZONDAN Medical Equipment Co., LtdPGJ2026-04-22
00786585793505SEJOYJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06942284601921MaynoviaJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06942284601938MaynoviaJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06942284601945MaynoviaJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06942284601952MaynoviaJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06970392211213MaynoviaJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06970392211244SEJOYJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06970392218793MaynoviaJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
06970392218724SEJOYJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-27
06938395500253HomedicsShenzhen Hexin ZONDAN Medical Equipment Co., LtdPGJ2026-03-13
00050428168721CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDPGJ2025-09-30
00050428168738CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDPGJ2025-09-30
00846841092695ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.PGJ2025-09-24
B635BIOKIT0100Biokit O2BIOTRICITY INCPGJ2025-09-24
00845717010139Veridian HealthcareVERIDIAN HEALTHCARE LLCPGJ2025-09-09
30845717010130Veridian HealthcareVERIDIAN HEALTHCARE LLCPGJ2025-09-09
00845717011945R.P.M. PROVERIDIAN HEALTHCARE LLCPGJ2025-09-08
00845717012164TrackstarVERIDIAN HEALTHCARE LLCPGJ2025-09-08
00846841092565ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.PGJ2025-07-22
00846841092954ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.PGJ2025-07-22
06942820462498ChoicemmedBeijing Choice Electronic Technology Co., Ltd.PGJ2025-04-27
00850000967014CMI HealthCMI HEALTH INC.PGJ2025-04-23
00850000967038CMI HealthCMI HEALTH INC.PGJ2025-04-23
00850000967052CMI HealthCMI HEALTH INC.PGJ2025-04-23
00850000967311CMI HealthCMI HEALTH INC.PGJ2025-01-17