IPY · Class I · 21 CFR 890.3490

FDA Product Code IPY: Orthosis, Lumbo-sacral

Leading manufacturers include Dow Corning Wright, Fred Sammons, Inc. and Danek Medical, Inc..

11

Total

11

Cleared

24d

Avg days

1979

Since

FDA 510(k) Cleared Orthosis, Lumbo-sacral Devices (Product Code IPY)

11 devices

1–11 of 11

Cleared Jan 14, 1983

LUMBOSACRAL SUPPORT

Danek Medical, Inc.

Physical Medicine · 28d

Cleared Aug 07, 1980

LUMBOSACRAL SUPPORTS & THORACO-LUMBO-SAC

Fred Sammons, Inc.

Physical Medicine · 14d

Cleared Feb 05, 1980

WRIGHT DOW CORNING SOFTGOODS W/DOW

Dow Corning Wright

Physical Medicine · 88d

About Product Code IPY - Regulatory Context

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 175,730 total devices indexed.

Latest clearance: Jan 17, 1983

Product Code Info

Code	IPY
Device class	Class I
CFR	21 CFR 890.3490
Panel	Physical Medicine

Verify on FDA.gov

View IPY classification on FDA.gov →