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FDA 510(k)

SENSORY ROLLER MASSAGER

K-Number: K833090 · 1983-10-14

ApplicantMaddak, Inc.
Decision Date1983-10-14
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SENSORY ROLLER MASSAGER is the device name listed in this FDA 510(k) record. The listed applicant is Maddak, Inc.. It received FDA 510(k) clearance on 1983-10-14 under 510(k) number K833090. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSORY ROLLER MASSAGER?

SENSORY ROLLER MASSAGER is a medical device that received FDA 510(k) clearance on 1983-10-14. The listed applicant is Maddak, Inc.. The 510(k) number is K833090.

When did SENSORY ROLLER MASSAGER receive FDA 510(k) clearance?

SENSORY ROLLER MASSAGER received FDA 510(k) clearance on 1983-10-14, under 510(k) number K833090.

Who is the listed applicant for SENSORY ROLLER MASSAGER?

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

What is the FDA product code for SENSORY ROLLER MASSAGER?

The FDA product code for SENSORY ROLLER MASSAGER is ISA.

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Other records listing Maddak, 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.

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Related Devices (Code: ISA)

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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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