FDA 510(k)

ICY COLD ICE CAP

K-Number: K830416 · 1983-03-10

Decision Date1983-03-10

Product CodeIME

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

ICY COLD ICE CAP is the device name listed in this FDA 510(k) record. The listed applicant is Ladora Ent.. It received FDA 510(k) clearance on 1983-03-10 under 510(k) number K830416. 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 ICY COLD ICE CAP?

ICY COLD ICE CAP is a medical device that received FDA 510(k) clearance on 1983-03-10. The listed applicant is Ladora Ent.. The 510(k) number is K830416.

When did ICY COLD ICE CAP receive FDA 510(k) clearance?

ICY COLD ICE CAP received FDA 510(k) clearance on 1983-03-10, under 510(k) number K830416.

Who is the listed applicant for ICY COLD ICE CAP?

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

What is the FDA product code for ICY COLD ICE CAP?

The FDA product code for ICY COLD ICE CAP 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

View on FDA Database →

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