← FDA Medical Device Classifications

Dynamometer, Nonpowered

HRW · Class I — Low Risk (general controls) · Orthopedic · 21 CFR 888.1250

Classification

FDA Product Code
HRW
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 888.1250
Review panel
NE
Medical specialty
Orthopedic
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Market data

Cleared 510(k) submissions
12
Registered establishments
46

Source

Authoritative
FDA Device Classification database
Machine
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