21 CFR 890.1925
Isokinetic testing and evaluation system
21 CFR 890.1925 is the regulation titled “Isokinetic testing and evaluation system” 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 0 on the same dates in 2025
- Most often cited with
- 21 CFR 807.81, 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
- 12024
- 02025
- 02026
The regulation
Read the text of 21 CFR 890.1925 (eCFR, as of Sep 1, 2026)
(a) Identification. An isokinetic testing and evaluation system is a rehabilitative exercise device intended for medical purposes, such as to measure, evaluate, and increase the strength of muscles and the range of motion of joints.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59230, Nov. 3, 1998]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 890.1925.
- 21 CFR 807.81When a premarket notification submission is required1 letter cites both
- 21 CFR 820.100Corrective and preventive action1 letter cites both
- 21 CFR 820.198Complaint files1 letter cites both
- 21 CFR 820.30Design controls1 letter cites both
- 21 CFR 820.75Process validation1 letter cites both
- 21 CFR 890.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)1 letter cites both
Latest letters citing it
The letter citing 21 CFR 890.1925 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.