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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[CITE: 21CFR890.1925]
 See Related Information on Isokinetic testing and evaluation system. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

PART 890 -- PHYSICAL MEDICINE DEVICES

Subpart B - Physical Medicine Diagnostic Devices

Sec. 890.1925 Isokinetic testing and evaluation system.

(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]

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