HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200

Sleeve, Limb, Compressible

HYGIA HEALTH SERVICES, INC.

The following data is part of a premarket notification filed by Hygia Health Services, Inc. with the FDA for Hygia Health Services Reprocessed Huntleigh Foot Wrap Models Fg 100, Fg 200.

Pre-market Notification Details

• Device ID: K012651
• 510k Number: K012651
• Device Name: HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200
• Classification: Sleeve, Limb, Compressible
• Applicant: HYGIA HEALTH SERVICES, INC. 2800 MILAN CT., SUITE 259 Birmingham, AL 35211
• Contact: Geoff M Fatzinger
• Correspondent: Geoff M Fatzinger; HYGIA HEALTH SERVICES, INC. 2800 MILAN CT., SUITE 259 Birmingham, AL 35211
• Product Code: JOW
• CFR Regulation Number: 870.5800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-08-13
• Decision Date: 2002-04-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30817357021456	K012651	000
30817357021371	K012651	000