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)

FO96 HANDY MASSAGER

K-Number: K931638 · 1994-03-28

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

Device Summary

FO96 HANDY 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 K931638. 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 FO96 HANDY MASSAGER?

FO96 HANDY 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 K931638.

When did FO96 HANDY MASSAGER receive FDA 510(k) clearance?

FO96 HANDY MASSAGER received FDA 510(k) clearance on 1994-03-28, under 510(k) number K931638.

Who is the listed applicant for FO96 HANDY 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 FO96 HANDY MASSAGER?

The FDA product code for FO96 HANDY MASSAGER 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.

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 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 ADAPTORK931637A013 FEMI-FORM FACIAL MASSAGERK920644F499 DELUXE ELECTRIC TOOTH BRUSH W/ STANDK914830A101 LITESSAGER

View all 13 devices →

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.

↑