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
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK140023 | Date16 Oct 2014 | StatusActive |
Official records
- FDA 510(k) database K140023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Elevation Ultralight Manual Wheelchair | 5520 / ELEVATION | B829201 | — | No longer on the market |
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Other devices filed under FDA product code IOR (Wheelchair, Mechanical).
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