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FDA 510(k)

WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL

K-Number: K012522 · 2001-10-18

ApplicantNational Therapy Products, Inc.
Decision Date2001-10-18
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL is the device name listed in this FDA 510(k) record. The listed applicant is National Therapy Products, Inc.. It received FDA 510(k) clearance on 2001-10-18 under 510(k) number K012522. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL?

WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL is a medical device that received FDA 510(k) clearance on 2001-10-18. The listed applicant is National Therapy Products, Inc.. The 510(k) number is K012522.

When did WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL receive FDA 510(k) clearance?

WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL received FDA 510(k) clearance on 2001-10-18, under 510(k) number K012522.

Who is the listed applicant for WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL?

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

What is the FDA product code for WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL?

The FDA product code for WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL is ITX.

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Other records listing National Therapy Products, 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.

K013212WAVELENGHT ULTRASOUND LOTION

Related Devices (Code: ITX)

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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