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FDA 510(k)

THERMAMED BATH

K-Number: K833631 · 1983-11-28

ApplicantBernlit Enterprises, Inc.
Decision Date1983-11-28
Product CodeIMC
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THERMAMED BATH is the device name listed in this FDA 510(k) record. The listed applicant is Bernlit Enterprises, Inc.. It received FDA 510(k) clearance on 1983-11-28 under 510(k) number K833631. The device is classified under product code IMC. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMAMED BATH?

THERMAMED BATH is a medical device that received FDA 510(k) clearance on 1983-11-28. The listed applicant is Bernlit Enterprises, Inc.. The 510(k) number is K833631.

When did THERMAMED BATH receive FDA 510(k) clearance?

THERMAMED BATH received FDA 510(k) clearance on 1983-11-28, under 510(k) number K833631.

Who is the listed applicant for THERMAMED BATH?

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

What is the FDA product code for THERMAMED BATH?

The FDA product code for THERMAMED BATH is IMC.

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Related Devices (Code: IMC)

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.

K093100REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA)Shenzhen Comfort Technology Co., Ltd.K022626MOISTURESTAY (REVLON)Raymond Industrial, Ltd.K013707SOFTIQUE, MODEL GI 11001Global TV Concepts, Ltd.K013328REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600Remington Products Company, LLCK001860PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRAHomedics, Inc.K991427PARAMED PARAFFIN WARMERDivi Intl. Co.

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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