21 CFR 890.3610 — Orthosis, Pneumatic Structure, Rigid

Physical Medicine (PM) · Part 890 Subpart D—Physical Medicine Prosthetic Devices · § 890.3610

Identification

A rigid pneumatic structure orthosis is a device intended for medical purposes to provide whole body support by means of a pressurized suit to help thoracic paraplegics walk.

Classification Rationale

Class III (premarket approval).

Product Codes

Product CodeDevice NameClassDevicesAttributes
IPOOrthosis, Pneumatic Structure, Rigid30
Innolitics

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