← FDA Medical Device Classifications

Stroller, Adaptive

LBE · Class I — Low Risk (general controls) · Physical Medicine · 21 CFR 890.3850

Classification

FDA Product Code

LBE

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 890.3850

Review panel

PM

Medical specialty

Physical Medicine

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

8

Registered establishments

7

Source

Authoritative

FDA Device Classification database

Machine

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