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Elevation

by PDG Product Design Group Inc

510(k) K140023

Elevation is a medical device (FDA Class I; FDA product code IOR, Wheelchair, Mechanical) made by PDG Product Design Group Inc, cleared under FDA 510(k) K140023 on 16 Oct 2014, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK140023 Date16 Oct 2014ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
IOR
FDA applicant
Pdg Product Design Group, Inc.
Device class
Class I
Regulation
21 CFR Part 890.3850
Advisory committee
Physical Medicine
FDA decision
SESE Substantially Equivalent

Devices cleared under K140023

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K140023
UDI-DISize and differences
Elevation Ultralight Manual Wheelchair
PDG Product Design Group Inc
5520 / ELEVATIONB829201 —No longer on the market

Similar devices

Other devices filed under FDA product code IOR (Wheelchair, Mechanical).

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