Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL

K-Number: K113660 · 2012-05-03

ApplicantCryotherapy Products, Inc.
Decision Date2012-05-03
Product CodeLKX
DecisionSubstantially Equivalent

Device Summary

COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL is the device name listed in this FDA 510(k) record. The listed applicant is Cryotherapy Products, Inc.. It received FDA 510(k) clearance on 2012-05-03 under 510(k) number K113660. The device is classified under product code LKX. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL?

COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL is a medical device that received FDA 510(k) clearance on 2012-05-03. The listed applicant is Cryotherapy Products, Inc.. The 510(k) number is K113660.

When did COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL receive FDA 510(k) clearance?

COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL received FDA 510(k) clearance on 2012-05-03, under 510(k) number K113660.

Who is the listed applicant for COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL?

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

What is the FDA product code for COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL?

The FDA product code for COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL is LKX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.K072414CRYOSTATLil Drug Store Products, Inc.K042564HEMOR-RITE CRYOTHERAPHYFama Holdings International CorpK012746ICE BATONBehive, Ltd.K981428ANU ICECryoptherapy Pain Relief Products, Inc.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.

↑