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FDA 510(k)

BACK MASSAGER B-400 ADJUSTABLE

K-Number: K832913 · 1983-11-07

ApplicantPollenex Associated Mills, Inc.
Decision Date1983-11-07
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BACK MASSAGER B-400 ADJUSTABLE is the device name listed in this FDA 510(k) record. The listed applicant is Pollenex Associated Mills, Inc.. It received FDA 510(k) clearance on 1983-11-07 under 510(k) number K832913. 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 BACK MASSAGER B-400 ADJUSTABLE?

BACK MASSAGER B-400 ADJUSTABLE is a medical device that received FDA 510(k) clearance on 1983-11-07. The listed applicant is Pollenex Associated Mills, Inc.. The 510(k) number is K832913.

When did BACK MASSAGER B-400 ADJUSTABLE receive FDA 510(k) clearance?

BACK MASSAGER B-400 ADJUSTABLE received FDA 510(k) clearance on 1983-11-07, under 510(k) number K832913.

Who is the listed applicant for BACK MASSAGER B-400 ADJUSTABLE?

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

What is the FDA product code for BACK MASSAGER B-400 ADJUSTABLE?

The FDA product code for BACK MASSAGER B-400 ADJUSTABLE is ISA.

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Other records listing Pollenex Associated Mills, 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.

K843010BP-800K843446DIGITAL SPHYGMOMANOMETER BP-2500K843009BP-1000

Related Devices (Code: ISA)

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.

K243488VMAT PROTermosaludK240358ShockPhysio Mobile (model SW3200 Basic)Shenzhen Dongdixin Technology Co., Ltd.K221865BTL-094BTL Industries, Inc.K210166Omnispec ED1000Medispec, Ltd.K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave TrtK220538DolorClast RadialE.M.S Electro Medical Systems S.A

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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