FDA 510(k)

PROVANT THERAPY SYSTEM

K-Number: K131979 · 2013-12-13

Decision Date2013-12-13

Product CodeILX

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

PROVANT THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Regenesis Biomedical, Inc.. It received FDA 510(k) clearance on 2013-12-13 under 510(k) number K131979. The device is classified under product code ILX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROVANT THERAPY SYSTEM?

PROVANT THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2013-12-13. The listed applicant is Regenesis Biomedical, Inc.. The 510(k) number is K131979.

When did PROVANT THERAPY SYSTEM receive FDA 510(k) clearance?

PROVANT THERAPY SYSTEM received FDA 510(k) clearance on 2013-12-13, under 510(k) number K131979.

Who is the listed applicant for PROVANT THERAPY SYSTEM?

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

What is the FDA product code for PROVANT THERAPY SYSTEM?

The FDA product code for PROVANT THERAPY SYSTEM is ILX.

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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Other records listing Regenesis Biomedical, Inc. as applicant

K223620Reprieve by RegenesisTM K091791PROVANT SYSTEM, MODEL 4201 K972093REGENESIS MODEL 42

Related Devices (Code: ILX)

K241395Active System; Avenue8Caerus Corporation K202337Pulsed electromagnetic field wrapHi-Dow International, Inc.K190251RecoveryRxBioelectronics Corporation K121702ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICEOrthocor Medical K121338ZEOBIIvivi Health Science, LLC K091791PROVANT SYSTEM, MODEL 4201Regenesis Biomedical, Inc.

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.