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FDA 510(k)

DERMATHERAPY, MODEL 22216

K-Number: K061242 · 2007-01-25

ApplicantPrecision Fabrics Group, Inc.
Decision Date2007-01-25
Product CodeFMW
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DERMATHERAPY, MODEL 22216 is the device name listed in this FDA 510(k) record. The listed applicant is Precision Fabrics Group, Inc.. It received FDA 510(k) clearance on 2007-01-25 under 510(k) number K061242. The device is classified under product code FMW. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMATHERAPY, MODEL 22216?

DERMATHERAPY, MODEL 22216 is a medical device that received FDA 510(k) clearance on 2007-01-25. The listed applicant is Precision Fabrics Group, Inc.. The 510(k) number is K061242.

When did DERMATHERAPY, MODEL 22216 receive FDA 510(k) clearance?

DERMATHERAPY, MODEL 22216 received FDA 510(k) clearance on 2007-01-25, under 510(k) number K061242.

Who is the listed applicant for DERMATHERAPY, MODEL 22216?

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

What is the FDA product code for DERMATHERAPY, MODEL 22216?

The FDA product code for DERMATHERAPY, MODEL 22216 is FMW.

Related Clinical Trials

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Other records listing Precision Fabrics Group, 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.

K152884DermaTherapy Bed Linens

Related Devices (Code: FMW)

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.

K152884DermaTherapy Bed LinensPrecision Fabrics Group, Inc.K001003Z-NETDemite LimitedK992702EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEMAllergy DirectK940327INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOWW. L. Gore & Associates, Inc.K935220CORE PREVENT MATTRESS MODIFICATIONPaladin Medical, Inc.K924807REUSABLE INCONTIENT UNDERPADPerfect Fit Industries, 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.

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