DJO, LLC

Address:3151 Scott St,Vista,CA,92081,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Pack, hot or cold, water circulating (ILO) (4) JOINT, ANKLE, EXTERNAL BRACE (ITW) (3) PACK, HOT OR COLD, DISPOSABLE (IMD) (3)

Premarket Exempt

No Yes

Clear

DONJOY ADVANTAGE - 00190446209256 Catalog Number :

Device Description : Delux Elastic Ankle, Tan, Medium

Device Class : 1

Duns Number: 081840873

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

DONJOY ADVANTAGE - 00190446209270 Catalog Number :

Device Description : Delux Elastic Ankle, Tan, XLarge

Device Class : 1

Duns Number: 081840873

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

DONJOY - 00190446220312 Catalog Number :

Device Description : DONJOY ICEMAN CLEARCUBE, K. PERMANENTE

Device Class : 2

Duns Number: 081840873

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : No

Device Count : 1

AIRCAST - 00190446222354 Catalog Number :

Device Description : CRYO/CUFF IC W/KNEE, MED, CHOA

Device Class : 2

Duns Number: 081840873

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : No

Device Count : 1

AIRCAST - 00190446222361 Catalog Number :

Device Description : CRYO/CUFF IC W/KNEE, LG, CHOA

Device Class : 2

Duns Number: 081840873

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : No

Device Count : 1

AIRCAST - 00190446222378 Catalog Number :

Device Description : CRYO/CUFF IC W/SHOULDER, CHOA

Device Class : 2

Duns Number: 081840873

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : No

Device Count : 1

DONJOY PERFORMANCE - 00190446227472 Catalog Number :

Device Description : COLD FORM GEL PACK 170MM X 80MM

Device Class : 1

Duns Number: 081840873

Premarket Exempt : Yes

Product Code : IMD

Prescription Use : No

Device Count : 1

DONJOY PERFORMANCE - 00190446227489 Catalog Number :

Device Description : COLD FORM GEL PACK 230MM X 127MM

Device Class : 1

Duns Number: 081840873

Premarket Exempt : Yes

Product Code : IMD

Prescription Use : No

Device Count : 1

DONJOY PERFORMANCE - 00190446227496 Catalog Number :

Device Description : COLD FORM GEL PACK 254MM X 180MM

Device Class : 1

Duns Number: 081840873

Premarket Exempt : Yes

Product Code : IMD

Prescription Use : No

Device Count : 1

DONJOY PERFORMANCE - 00190446237815 Catalog Number :

Device Description : BIONIC SPEED-WRAP ANKLE,BLACK, SMALL

Device Class : 1

Duns Number: 081840873

Premarket Exempt : Yes

Product Code : ITW

Prescription Use : No

Device Count : 1

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