FDA 510(k)

HEAT PACK

K-Number: K841698 · 1984-05-10

Decision Date1984-05-10

Product CodeIMA

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

HEAT PACK is the device name listed in this FDA 510(k) record. The listed applicant is Maddak, Inc.. It received FDA 510(k) clearance on 1984-05-10 under 510(k) number K841698. The device is classified under product code IMA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEAT PACK?

HEAT PACK is a medical device that received FDA 510(k) clearance on 1984-05-10. The listed applicant is Maddak, Inc.. The 510(k) number is K841698.

When did HEAT PACK receive FDA 510(k) clearance?

HEAT PACK received FDA 510(k) clearance on 1984-05-10, under 510(k) number K841698.

Who is the listed applicant for HEAT PACK?

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

What is the FDA product code for HEAT PACK?

The FDA product code for HEAT PACK is IMA.

Other records listing Maddak, 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.

K841700WALK & ROLL K841695CRAWLER K841693STANDING FRAME K841697HYDRO-THERO PAD K841692PRONE STANDER K841691SPLIT SEAT POSITIONING CHAIR

View all 51 devices →

Related Devices (Code: IMA)

K950701WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLERWahl Clipper Corp.K832803STEAM PAK MOIST HEATElectro-Med Health Industries, Inc.K823622INSULATED THERMOELASTOMER MITTFred Sammons, Inc.K803177MOIST HEAT PACKDuro-Med Ind., Inc.K791653REUSABLE MOIST HEAT PACKTru-Eze Mfg. Co., Inc.K790904STAO-HOTPACKStaodynamics, Inc.

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.