Motive Muscle Stimulator for Lower Back (OT01-1003)
K-Number: K253478 · 2025-11-06
ApplicantMotive Health, Inc.
Decision Date2025-11-06
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Motive Muscle Stimulator for Lower Back (OT01-1003) is a medical device manufactured by Motive Health, Inc.. It received FDA 510(k) clearance on 2025-11-06 under approval number K253478. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Motive Muscle Stimulator for Lower Back (OT01-1003)?
Motive Muscle Stimulator for Lower Back (OT01-1003) is a medical device that received FDA 510(k) clearance on 2025-11-06. It is manufactured by Motive Health, Inc.. The 510(k) number is K253478.
When was Motive Muscle Stimulator for Lower Back (OT01-1003) approved by the FDA?
Motive Muscle Stimulator for Lower Back (OT01-1003) received FDA 510(k) clearance on 2025-11-06, under approval number K253478.
What company makes Motive Muscle Stimulator for Lower Back (OT01-1003)?
Motive Muscle Stimulator for Lower Back (OT01-1003) is manufactured by Motive Health, Inc..
What is the FDA product code for Motive Muscle Stimulator for Lower Back (OT01-1003)?
The FDA product code for Motive Muscle Stimulator for Lower Back (OT01-1003) is NGX.
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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.