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FDA 510(k)

THERACUSHION MODEL 1000

K-Number: K861834 · 1986-05-27

ApplicantGeneral Physiotherapy, Inc.
Decision Date1986-05-27
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THERACUSHION MODEL 1000 is the device name listed in this FDA 510(k) record. The listed applicant is General Physiotherapy, Inc.. It received FDA 510(k) clearance on 1986-05-27 under 510(k) number K861834. 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 THERACUSHION MODEL 1000?

THERACUSHION MODEL 1000 is a medical device that received FDA 510(k) clearance on 1986-05-27. The listed applicant is General Physiotherapy, Inc.. The 510(k) number is K861834.

When did THERACUSHION MODEL 1000 receive FDA 510(k) clearance?

THERACUSHION MODEL 1000 received FDA 510(k) clearance on 1986-05-27, under 510(k) number K861834.

Who is the listed applicant for THERACUSHION MODEL 1000?

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

What is the FDA product code for THERACUSHION MODEL 1000?

The FDA product code for THERACUSHION MODEL 1000 is ISA.

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Other records listing General Physiotherapy, 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.

K870939VIBRACAREK863383FACIAL MASSAGER, BATTERY POWEREDK855129NEOCUSSOR (MASSAGER, BATTERY) POWEREDK853710THERACUSHIONK852944FLEXIMATIC MASSAGERK850047SANYO ELECTRONIC MUSCLE STIMULATORS

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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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