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FDA 510(k)

THUMPER (VIBRATOR/MASSAGER)

K-Number: K860159 · 1986-02-06

ApplicantWellness Innovations Corp.
Decision Date1986-02-06
Product CodeIRO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THUMPER (VIBRATOR/MASSAGER) is the device name listed in this FDA 510(k) record. The listed applicant is Wellness Innovations Corp.. It received FDA 510(k) clearance on 1986-02-06 under 510(k) number K860159. 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 THUMPER (VIBRATOR/MASSAGER)?

THUMPER (VIBRATOR/MASSAGER) is a medical device that received FDA 510(k) clearance on 1986-02-06. The listed applicant is Wellness Innovations Corp.. The 510(k) number is K860159.

When did THUMPER (VIBRATOR/MASSAGER) receive FDA 510(k) clearance?

THUMPER (VIBRATOR/MASSAGER) received FDA 510(k) clearance on 1986-02-06, under 510(k) number K860159.

Who is the listed applicant for THUMPER (VIBRATOR/MASSAGER)?

The FDA 510(k) record lists Wellness Innovations Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THUMPER (VIBRATOR/MASSAGER)?

The FDA product code for THUMPER (VIBRATOR/MASSAGER) is IRO.

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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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