21 CFR 890.3900
Standup wheelchair
21 CFR 890.3900 is the regulation titled “Standup wheelchair” in 21 CFR Part 890, Physical Medicine Devices. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 803.17, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a medical device letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 12025
- 02026
What FDA writes when it cites it
The finding headings that cite 21 CFR 890.3900 most often, as written in the letters.
- 1 letterFailure to establish and maintain a quality system that is appropriate for the specific medical devices designed and manufactured as required by 21 CFR 820.5
The regulation
Read the text of 21 CFR 890.3900 (eCFR, as of Sep 1, 2026)
(a) Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.
(b) Classification. Class II (performance standards).
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 890.3900.
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1 letter cites both
- 21 CFR 820.100Corrective and preventive action1 letter cites both
- 21 CFR 820.120Device labeling1 letter cites both
- 21 CFR 820.130Device packaging1 letter cites both
- 21 CFR 820.140Handling1 letter cites both
- 21 CFR 820.150Storage1 letter cites both
- 21 CFR 820.160Distribution1 letter cites both
- 21 CFR 820.170Installation1 letter cites both
Latest letters citing it
The letter citing 21 CFR 890.3900 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.