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Highlander Cpl

by Harmar Summit, LLC 96 variants

Highlander (CPL0400EDCI) is an assistive passenger lift (FDA Class II; FDA product code ING, Elevator, wheelchair, portable) made by Harmar Summit, LLC, cleared under FDA 510(k) K091881 on 1 Jul 2009 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00817650020193), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K091881

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817650020193 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK091881 Date1 Jul 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K091881 decided 1 Jul 2009 Active
  • FDA GUDID UDI-DI 00817650020193 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K091881
  2. Listed FDA GUDID 00817650020193

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Highlander
Generic name
Assistive passenger lift
Model / Ref / Catalog
CPL, CPL0400EDCI
Primary DI / UDI-DI
00817650020193
510(k) Number
FDA product code
ING
GMDN term
Assistive passenger lift
Device class
Class II
Regulation number
890.3930
GUDID distribution status
In Commercial Distribution

Related devices

Category: Assistive passenger lift

Cleared under the same submission (K091881)

and 8 more cleared under K091881

Similar devices

Also classified as Assistive passenger lift.

Similar devices

Other devices filed under FDA product code ING (Elevator, wheelchair, portable).

Other devices from Harmar Summit, LLC

See all devices from Harmar Summit, LLC →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)