WARM'N FORM SPORTS SUPPORTS

Orthosis, Limb Brace

JEROME MEDICAL

The following data is part of a premarket notification filed by Jerome Medical with the FDA for Warm'n Form Sports Supports.

Pre-market Notification Details

Device IDK821582
510k NumberK821582
Device Name:WARM'N FORM SPORTS SUPPORTS
ClassificationOrthosis, Limb Brace
Applicant JEROME MEDICAL 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeIQI  
CFR Regulation Number890.3475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-05-28
Decision Date1982-06-10

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