Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list 21st Century Scientific, Inc. with 3 510(k) clearances and 2 warning letters. The most recent is a warning letter dated Nov 4, 2021: Warning letter: Medical Devices.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Nov 4, 2021 | Warning letter: Medical DevicesCDRH | Warning letters |
| Sep 3, 2020 | BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power WheelchairK193599 · ITI | 510(k) clearances |
| May 13, 2019 | Warning letter: Complaint handling, MDR reporting, Design controlsCDRH | Warning letters |
| Oct 13, 1995 | SIDEKICK POWER WHEELCHAIRK954044 · ITI | 510(k) clearances |
| Mar 26, 1990 | BOUNDER VA POWER WHEELCHAIRK901210 · ITI | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
