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FDA 510(k)

BACK RIE

K-Number: K813099 · 1981-11-24

ApplicantBack Rite
Decision Date1981-11-24
Product CodeION
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BACK RIE is the device name listed in this FDA 510(k) record. The listed applicant is Back Rite. It received FDA 510(k) clearance on 1981-11-24 under 510(k) number K813099. The device is classified under product code ION. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACK RIE?

BACK RIE is a medical device that received FDA 510(k) clearance on 1981-11-24. The listed applicant is Back Rite. The 510(k) number is K813099.

When did BACK RIE receive FDA 510(k) clearance?

BACK RIE received FDA 510(k) clearance on 1981-11-24, under 510(k) number K813099.

Who is the listed applicant for BACK RIE?

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

What is the FDA product code for BACK RIE?

The FDA product code for BACK RIE is ION.

Related Devices (Code: ION)

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.

K120783ABLE-XIm-Able, Ltd.K885343STANDEXAlt, Inc.K851065GRAVITY KING (DEEMED SE 87/09/18)Unique Functional ProductsK840551MOBILIZERLossing Orthopedic, Inc.K833870KNEE WALKERMaddak, Inc.K833249FITNESSFitness Equipment Co., Inc.

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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