FDA 510(k)

ANU ICE

K-Number: K981428 · 1998-07-07

ApplicantCryoptherapy Pain Relief Products, Inc.

Decision Date1998-07-07

Product CodeLKX

DecisionSubstantially Equivalent

Device Summary

ANU ICE is the device name listed in this FDA 510(k) record. The listed applicant is Cryoptherapy Pain Relief Products, Inc.. It received FDA 510(k) clearance on 1998-07-07 under 510(k) number K981428. The device is classified under product code LKX. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANU ICE?

ANU ICE is a medical device that received FDA 510(k) clearance on 1998-07-07. The listed applicant is Cryoptherapy Pain Relief Products, Inc.. The 510(k) number is K981428.

When did ANU ICE receive FDA 510(k) clearance?

ANU ICE received FDA 510(k) clearance on 1998-07-07, under 510(k) number K981428.

Who is the listed applicant for ANU ICE?

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

What is the FDA product code for ANU ICE?

The FDA product code for ANU ICE is LKX.

Related Devices (Code: LKX)

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.

K172358InstaliefPrivi Medical Pte, Ltd.K113660COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICALCryotherapy Products, Inc.K072414CRYOSTATLil Drug Store Products, Inc.K042564HEMOR-RITE CRYOTHERAPHYFama Holdings International Corp K012746ICE BATONBehive, Ltd.K973590HEMORRELIEF DEVICEA.Stein - Regulatory Affairs Consulting

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.