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FDA 510(k)

PM830 ELECTRIC MASSAGER

K-Number: K891394 · 1989-04-10

ApplicantBack IN Action, Inc.
Decision Date1989-04-10
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PM830 ELECTRIC MASSAGER is the device name listed in this FDA 510(k) record. The listed applicant is Back IN Action, Inc.. It received FDA 510(k) clearance on 1989-04-10 under 510(k) number K891394. 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 PM830 ELECTRIC MASSAGER?

PM830 ELECTRIC MASSAGER is a medical device that received FDA 510(k) clearance on 1989-04-10. The listed applicant is Back IN Action, Inc.. The 510(k) number is K891394.

When did PM830 ELECTRIC MASSAGER receive FDA 510(k) clearance?

PM830 ELECTRIC MASSAGER received FDA 510(k) clearance on 1989-04-10, under 510(k) number K891394.

Who is the listed applicant for PM830 ELECTRIC MASSAGER?

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

What is the FDA product code for PM830 ELECTRIC MASSAGER?

The FDA product code for PM830 ELECTRIC MASSAGER is ISA.

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 Back IN Action, 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.

K891458SW 803 LOW FREQUENCY STIMULATOR DANA TOUCH

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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