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FDA 510(k)

CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES)

K-Number: K945603 · 1995-02-09

ApplicantHeadwaters, Inc.
Decision Date1995-02-09
Product CodeIRO
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES) is the device name listed in this FDA 510(k) record. The listed applicant is Headwaters, Inc.. It received FDA 510(k) clearance on 1995-02-09 under 510(k) number K945603. The device is classified under product code IRO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES)?

CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES) is a medical device that received FDA 510(k) clearance on 1995-02-09. The listed applicant is Headwaters, Inc.. The 510(k) number is K945603.

When did CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES) receive FDA 510(k) clearance?

CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES) received FDA 510(k) clearance on 1995-02-09, under 510(k) number K945603.

Who is the listed applicant for CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES)?

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

What is the FDA product code for CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES)?

The FDA product code for CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES) is IRO.

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.

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Related Devices (Code: IRO)

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.

K955160COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGEREverapex Design & Marketing Corp.K955250QI GONG MASSAGEREast Health Development Group, Inc.K954203MASSAGER THERAPUTIC, ELECTRICCisco Sales Corp.K952916SHIATSU MASTER MASSAGER CUSHIONKinsei Shiatsu, Inc.K951414CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIRChampion Mfg. Corp.K950441CONAIR FAMILY FITNESS BODY ENERGYConair Corp.

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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