FDA 510(k)

PV01 PVDF Effort Sensor

K-Number: K251480 · 2025-08-29

Decision Date2025-08-29

Product CodeSFK

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

PV01 PVDF Effort Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Neurotronics, LLC. It received FDA 510(k) clearance on 2025-08-29 under 510(k) number K251480. The device is classified under product code SFK. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PV01 PVDF Effort Sensor?

PV01 PVDF Effort Sensor is a medical device that received FDA 510(k) clearance on 2025-08-29. The listed applicant is Neurotronics, LLC. The 510(k) number is K251480.

When did PV01 PVDF Effort Sensor receive FDA 510(k) clearance?

PV01 PVDF Effort Sensor received FDA 510(k) clearance on 2025-08-29, under 510(k) number K251480.

Who is the listed applicant for PV01 PVDF Effort Sensor?

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

What is the FDA product code for PV01 PVDF Effort Sensor?

The FDA product code for PV01 PVDF Effort Sensor is SFK.

Other records listing Neurotronics, LLC 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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.