510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OIRClass III

Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

Unknown
FDA source (opens on fda.gov)

OIR is the FDA product code for Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator, a class III device type. FDA's definition for this code reads: "The device is intended for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but who lack control of their diaphragms. The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day. For use only in...". As of , FDA records hold no 510(k) clearances under this code and 2 recalls.

Classification record

Product code
OIR
Device name
Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator
FDA definition
The device is intended for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but who lack control of their diaphragms. The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day. For use only in patients 18 years of age or older.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
2

Companies listing this code with FDA

Companies whose registered establishments list this code