HARMAR SUMMIT, LLC

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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

Powered stairway chair lift (PCD) (6) Elevator, wheelchair, portable (ING) (2) Permanently mounted wheelchair platform lift (PCE) (2)

Premarket Exempt

No Yes

Clear

Helix - 00817650020001 Catalog Number : CSL500

Device Description : Heim RH Nkey chassis

Device Class : 2

Duns Number: 144008062

Premarket Exempt : Yes

Product Code : PCD

Prescription Use : No

Device Count : 1

Helix - 00817650020018 Catalog Number : CSL500

Device Description : Heim LH Nkey chassis

Device Class : 2

Duns Number: 144008062

Premarket Exempt : Yes

Product Code : PCD

Prescription Use : No

Device Count : 1

Helix - 00817650020025 Catalog Number : CSL500

Device Description : Helix 3 RH NKEY Indoor chassis

Device Class : 2

Duns Number: 144008062

Premarket Exempt : Yes

Product Code : PCD

Prescription Use : No

Device Count : 1

Helix - 00817650020049 Catalog Number : CSL500

Device Description : Helix 3 LH NKEY Indoor chassis

Device Class : 2

Duns Number: 144008062

Premarket Exempt : Yes

Product Code : PCD

Prescription Use : No

Device Count : 1

Guardsman - 00817650020063 Catalog Number : CSL500

Device Description : Helix 3 RH NKEY Indoor chassis

Device Class : 2

Duns Number: 144008062

Premarket Exempt : Yes

Product Code : PCD

Prescription Use : No

Device Count : 1

Guardsman - 00817650020070 Catalog Number : CSL500

Device Description : Helix 3 LH NKEY Indoor chassis

Device Class : 2

Duns Number: 144008062

Premarket Exempt : Yes

Product Code : PCD

Prescription Use : No

Device Count : 1

Sierra - 00817650020087 Catalog Number : IL500

Device Description : Incline stairway lift Indoor

Device Class : 2

Duns Number: 144008062

Premarket Exempt : Yes

Product Code : PCE

Prescription Use : No

Device Count : 1

Sierra - 00817650020094 Catalog Number : IL500

Device Description : Incline stairway lift outdoor

Device Class : 2

Duns Number: 144008062

Premarket Exempt : Yes

Product Code : PCE

Prescription Use : No

Device Count : 1

HERCULES II - 00817650020100 Catalog Number : AG 0400PACI

Device Description : AMERIGLIDE, COMMERCIAL PLATFORM LIFT 750 LB, 400 PORTABLE, AC, INSIDE

Device Class : 2

Duns Number: 144008062

Premarket Exempt : Yes

Product Code : ING

Prescription Use : No

Device Count : 1

HIGHLANDER - 00817650020117 Catalog Number : CPL0400SACI

Device Description : COMMERCIAL PLATFORM LIFT, 400 STANDARD, AC, INSIDE

Device Class : 2

Duns Number: 144008062

Premarket Exempt : No

Product Code : ING

Prescription Use : No

Device Count : 1

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