Pediatric Position Holder

PRN · Class I — Low Risk (general controls) · General Hospital · 21 CFR 880.5680

Classification

FDA Product Code: PRN
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 880.5680
Review panel: HO
Medical specialty: General Hospital
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Device used to physically restrain a pediatric patient for a short surgical or clinical procedure such as circumcision. Not intended for prolonged positioning.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 12

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown