ISOCOMFORTER

Pack, Hot Or Cold, Water Circulating

ISOCOMFORTER, INC.

The following data is part of a premarket notification filed by Isocomforter, Inc. with the FDA for Isocomforter.

Pre-market Notification Details

• Device ID: K936143
• 510k Number: K936143
• Device Name: ISOCOMFORTER
• Classification: Pack, Hot Or Cold, Water Circulating
• Applicant: ISOCOMFORTER, INC. 4445-B BRETON RD., S.E., SUITE 310 Kentwood, MI 49508
• Contact: Imad Mahawili
• Correspondent: Imad Mahawili; ISOCOMFORTER, INC. 4445-B BRETON RD., S.E., SUITE 310 Kentwood, MI 49508
• Product Code: ILO
• CFR Regulation Number: 890.5720 [🔎]
• Decision: Substantially Equivalent For Some Indications (SN)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-12-27
• Decision Date: 1994-07-12