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FDA 510(k)

SLEEPRIGHT

K-Number: K100545 · 2010-06-04

ApplicantPower Products, Inc.-Splintek
Decision Date2010-06-04
Product CodeOBR
DecisionSubstantially Equivalent

Device Summary

SLEEPRIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Power Products, Inc.-Splintek. It received FDA 510(k) clearance on 2010-06-04 under 510(k) number K100545. The device is classified under product code OBR. Product code OBR falls under the category of Orthopedic, which includes orthopedic implants, fixation devices, and surgical instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLEEPRIGHT?

SLEEPRIGHT is a medical device that received FDA 510(k) clearance on 2010-06-04. The listed applicant is Power Products, Inc.-Splintek. The 510(k) number is K100545.

When did SLEEPRIGHT receive FDA 510(k) clearance?

SLEEPRIGHT received FDA 510(k) clearance on 2010-06-04, under 510(k) number K100545.

Who is the listed applicant for SLEEPRIGHT?

The FDA 510(k) record lists Power Products, Inc.-Splintek as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SLEEPRIGHT?

The FDA product code for SLEEPRIGHT is OBR. This falls under the Orthopedic category.

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 Power Products, Inc.-Splintek 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.

K071404SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCEK022809EZ SPLINT & EZ SPLINT PM

Related Devices (Code: OBR)

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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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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