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FDA 510(k)

A013 FEMI-FORM FACIAL MASSAGER

K-Number: K931637 · 1994-03-28

ApplicantFairform Mfg., Co., Ltd.
Decision Date1994-03-28
Product CodeIRO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

A013 FEMI-FORM FACIAL MASSAGER is the device name listed in this FDA 510(k) record. The listed applicant is Fairform Mfg., Co., Ltd.. It received FDA 510(k) clearance on 1994-03-28 under 510(k) number K931637. The device is classified under product code IRO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A013 FEMI-FORM FACIAL MASSAGER?

A013 FEMI-FORM FACIAL MASSAGER is a medical device that received FDA 510(k) clearance on 1994-03-28. The listed applicant is Fairform Mfg., Co., Ltd.. The 510(k) number is K931637.

When did A013 FEMI-FORM FACIAL MASSAGER receive FDA 510(k) clearance?

A013 FEMI-FORM FACIAL MASSAGER received FDA 510(k) clearance on 1994-03-28, under 510(k) number K931637.

Who is the listed applicant for A013 FEMI-FORM FACIAL MASSAGER?

The FDA 510(k) record lists Fairform Mfg., Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A013 FEMI-FORM FACIAL MASSAGER?

The FDA product code for A013 FEMI-FORM FACIAL MASSAGER is IRO.

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Other records listing Fairform Mfg., Co., Ltd. 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.

K931640AO11 BODY MASSAGERK931636FO18/FO98 SCRUBOFLEX SHOWERPROOF BRUSH MASSAGERK931639F183 AC-MINI MASSAGER WITH UL APROVED ADAPTORK931638FO96 HANDY MASSAGERK920644F499 DELUXE ELECTRIC TOOTH BRUSH W/ STANDK914830A101 LITESSAGER

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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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