GENDRON, INC.

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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

Chair, With Casters (INM) (10)

Premarket Exempt

Yes

Clear

NA - 00842307100218 Catalog Number :

Device Description : WHEELCHAIR,24X20DP,REM ARM,Q/R700 LB CAPACITY,REGENCY XL2000

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100225 Catalog Number :

Device Description : WHEELCHAIR,26X20DP,REM ARM,Q/R700 LB CAPACITY,REGENCY XL2000

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100232 Catalog Number :

Device Description : WHEELCHAIR,26X22DP,REM ARM,Q/R700 LB CAPACITY,REGENCY XL2000

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100249 Catalog Number :

Device Description : WHEELCHAIR,28X20DP,REM ARM,Q/R700 LB CAPACITY,REGENCY XL2000

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100256 Catalog Number :

Device Description : WHEELCHAIR,28X20DP,REM ARM,Q/R 700 LB CAPACITY,REGENCY XL2000

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100263 Catalog Number :

Device Description : WHEELCHAIR,28X20DP,REM ARM,Q/R700 LB CAPACITY,REGENCY XL2000

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100270 Catalog Number :

Device Description : WHEELCHAIR,28X20DP,REM ARM,Q/R 700 LB CAPACITY,REGENCY XL2000

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100287 Catalog Number :

Device Description : WHEELCHAIR,28X22DP,REM ARM,Q/R700 LB CAPACITY,REGENCY XL2000

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100294 Catalog Number :

Device Description : WHEELCHAIR,30X18DP,REM ARM,Q/R700 LB CAPACITY,REGENCY XL2000

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

NA - 00842307100300 Catalog Number :

Device Description : WHEELCHAIR,30X18DP,REM ARM,Q/R 700 LB CAPACITY,REGENCY XL2000

Device Class : 1

Duns Number: 054164587

Premarket Exempt : Yes

Product Code : INM

Prescription Use : No

Device Count : 1

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