FDA.reportPublic FDA data

Clever Choice

Primary DI
00898302001883
Brand
Clever Choice
Company
SIMPLE DIAGNOSTICS INC
Model
Orthopedic Knee Brace
Device description
Orthopedic Knee Brace
Published
2018-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRIOrthosis, Truncal/Orthosis, Limb

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRIOrthosis, Truncal/Orthosis, LimbPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00898302001883PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00898302001883008983020018838983020018830898302001883

GMDN Terms#

Term, Definition table
TermDefinition
Tubular support bandage, non-latex, reusableA tubular, elastic fabric (e.g., polyamide, Lycra) sleeve intended to be externally worn on a limb to provide support or local pressure to a part of the body, especially a joint, for various preventative/therapeutic applications (e.g., support soft tissue injuries) while enabling movement. Sometimes referred to as a tubigrip, it may be designed to accommodate one or more anatomies (e.g., ankles, knees, wrists). It is not designed specifically to apply an even or graduated force to the limb (i.e., not a compression/pressure garment). This is a single-patient, reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.877.342.2385customerservice@simplediagnostics.com

Regulatory Flags#

DUNS number
004135503
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00898302140230Comfort EZ Safety LancetCLES1002398302-0140-232025-11-25
00898302140438Clever Choice Comfort EZ"Insulin Syringe 27G 1cc 1/2"""98302-0140-432025-11-25
10898302140435Clever Choice Comfort EZInsulin Syringe 27G 1cc 1/2"98302-0140-432025-11-25
00898302140193Clever ChoiceFace Mask2022-01-04
00898302001890Clever ChoiceOrthopedic Back Brace2018-09-27
00898302001975Pharmacist ChoiceAlcohol Prep Pad 100ct62379-005-062016-08-01
00850002860382Clever Choice Peak Flow MeterSDI-PFM50002-0860-382019-11-04
00898302001456Clever ChoiceWhisper Aire Pediatric Child Nebulizer2017-01-02
00898302001449Clever ChoiceWhisper Aire Nebulizer2017-01-02
00898302140698Clever ChoiceSDI-BPMCA98302-0140-692023-02-14
00898302014180Clever ChoiceSDI-1486A BPM98302-0014-182023-02-13
00898302140124Clever ChoiceSDI-1796 BPM98302-0140-122022-06-07
00898302001005Simple DiagnosticsLAND98302-0001-002020-09-01
00898302001043Pharmacist ChoiceLAN3098302-0001-042020-09-01
00898302001609Pharmacist ChoiceLAN3198302-0001-602020-09-01
00898302140711Pharmacist ChoiceLAN3398302-0140-712020-09-02
00850002860603Pharmacist ChoiceULT3150002-0860-602022-10-19
00898302140209Comfort EZ Safety LancetCLES1002898302-0140-202022-10-19
10850002860600Pharmacist ChoiceULT3150002-0860-602022-10-19
20898302140203Comfort EZ Safety LancetCLES1002898302-0140-202022-10-19

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10810178881564CoreTechVIVE HEALTH LLCMRI2025-05-19