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FDA 510(k)

PASSIVE HEAT PADS

K-Number: K821692 · 1982-07-13

ApplicantBiotone International, Inc.
Decision Date1982-07-13
Product CodeIRT
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PASSIVE HEAT PADS is the device name listed in this FDA 510(k) record. The listed applicant is Biotone International, Inc.. It received FDA 510(k) clearance on 1982-07-13 under 510(k) number K821692. The device is classified under product code IRT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PASSIVE HEAT PADS?

PASSIVE HEAT PADS is a medical device that received FDA 510(k) clearance on 1982-07-13. The listed applicant is Biotone International, Inc.. The 510(k) number is K821692.

When did PASSIVE HEAT PADS receive FDA 510(k) clearance?

PASSIVE HEAT PADS received FDA 510(k) clearance on 1982-07-13, under 510(k) number K821692.

Who is the listed applicant for PASSIVE HEAT PADS?

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

What is the FDA product code for PASSIVE HEAT PADS?

The FDA product code for PASSIVE HEAT PADS is IRT.

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

Other records listing Biotone International, Inc. as applicant

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.

K821691STIMRITEK812538ELITEK811737BIO-TONE MODEL 4

Related Devices (Code: IRT)

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.

K250047bite away twomibeTec GmbHK220514bite away neomibeTec GmbHK160943Bite AwayRiemser PharmaK111273FIR HEAT THERAPHY SYSYEMSShenzhen Anpan Technology Co., Ltd.K072534BIO-MAT 2000Richway Intl., Inc.K963887PT-PAC PORTABLE HEATING PADAnthony A. Chiurco

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.

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