HOTPAD

Pack, Hot Or Cold, Reusable

TEN COMFORT CORP.

The following data is part of a premarket notification filed by Ten Comfort Corp. with the FDA for Hotpad.

Pre-market Notification Details

• Device ID: K915876
• 510k Number: K915876
• Device Name: HOTPAD
• Classification: Pack, Hot Or Cold, Reusable
• Applicant: TEN COMFORT CORP. P.O. BOX 577 YUNG-HO Taiwan R.o.c., CN
• Contact: Charles Wong
• Correspondent: Charles Wong; TEN COMFORT CORP. P.O. BOX 577 YUNG-HO Taiwan R.o.c., CN
• Product Code: IME
• CFR Regulation Number: 890.5700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-12-19
• Decision Date: 1993-02-12