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IRR · Class I — Low Risk (general controls) · Physical Medicine · 21 CFR 890.5380

Classification

FDA Product Code

IRR

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 890.5380

Review panel

PM

Medical specialty

Physical Medicine

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

1

Registered establishments

6

Source

Authoritative

FDA Device Classification database

Machine

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