FDA.reportPublic FDA data

Omnipad Light Therapy, Dual 5x7 Pads

Primary DI
10858703006906
Brand
Omnipad Light Therapy, Dual 5x7 Pads
Company
ACCELERATED CARE PLUS CORP
Model
76896
Device description
Infrared lamp for therapeutic healing
Published
2016-08-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060191000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060191000ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNITAccelerated Care Plus Corp.2006-07-12ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858703006906PackageGS124In Commercial Distribution
00858703006061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085870300690610858703006906
00858703006061008587030060618587030060610858703006061

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal infrared phototherapy unit, non-wearableA mains electricity (AC-powered) device intended to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It may be available in a variety of forms however it is not intended to be worn on the body.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-350-1100customersupport@acplus.com

Regulatory Flags#

DUNS number
828331616
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858703006054Neuroprobe 500 Pro140500B2016-08-16
00858703006252Ultraphonic (250ml Bottle)455392016-09-06
00858703006269Ultraphonic, 5 Liter w/ bottle320602016-09-06
00858703006061Omnipad Light Therapy, Dual 5x7 Pads768962016-08-16
00858703006399OmniCycle Elite 7 Inch Screen Motorized Therapeutic Exercise SystemA007-5332024-10-21
00858703006382OmniTour System300800T2024-09-10
00858703006207Synchrony Oro-Facial sEMG Electrode618792016-08-16
00858703006214Electrodes Pharyngeal sEMG341842016-08-16
00858703006375OmniTourOmniTourSoftware2023-09-12
00858703006313OmniFlow SoftwareFlowSoftware2023-09-06
00858703006092OmniStim FX2 Portable PENS300200A-12016-08-16
00858703006276OmniFlow Therapy System100FLO2023-09-12
00858703006344ACPlus Respiratory AssessmentARASoftware2023-09-12
00858703006368ACPlus Platform100ACPLUS2023-09-12
B179OMNI13E87E4OmnisEMG441442023-09-06
00858703006337Synchrony Dysphagia Solutions by ACP300800A2023-09-01
00858703006351OmniVR Elite300600C2023-09-01
00858703006139OmniVersa100FXF2023-08-17
00858703006320OmniME100MTS2023-08-17
00858703006078Megapulse II19030292016-08-16

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