FDA 510(k)

KOLD WRAP

K-Number: K801365 · 1980-08-07

Decision Date1980-08-07

Product CodeIME

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

KOLD WRAP is the device name listed in this FDA 510(k) record. The listed applicant is Romaine, Inc.. It received FDA 510(k) clearance on 1980-08-07 under 510(k) number K801365. The device is classified under product code IME. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOLD WRAP?

KOLD WRAP is a medical device that received FDA 510(k) clearance on 1980-08-07. The listed applicant is Romaine, Inc.. The 510(k) number is K801365.

When did KOLD WRAP receive FDA 510(k) clearance?

KOLD WRAP received FDA 510(k) clearance on 1980-08-07, under 510(k) number K801365.

Who is the listed applicant for KOLD WRAP?

The FDA 510(k) record lists Romaine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KOLD WRAP?

The FDA product code for KOLD WRAP is IME.

Related Devices (Code: IME)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K923627COLD PACKFriendmed Products K915876HOTPADTen Comfort Corp.K921446HOT OR COLD PACK (THERMIPAQ)Thermionics Corp.K905207MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESSMicro Surgical Instruments Corp.K882413SUBOCCIPITAL ICE PILLOWFerguson Medical K863654RE-HEATER, HOT PACKK & L Ent.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.