← FDA Medical Device Classifications

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INF · Class I — Low Risk (general controls) · Physical Medicine · 21 CFR 890.3940

Classification

FDA Product Code
INF
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 890.3940
Review panel
PM
Medical specialty
Physical Medicine
Submission type
4
GMP exempt
Y
Life sustaining
N
Implant
N
Third-party review
N

Market data

Cleared 510(k) submissions
5
Registered establishments
32

Source

Authoritative
FDA Device Classification database
Machine
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