Identifiers
- 510(k) Number
- K093259 FDA 510(k)
- FDA Product Code
- IPF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5850 FDA 510(k)
- Regulation Number
- 890.5850 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ARP RX100 is a powered muscle stimulator, as defined by regulation number 21 CFR 890.5850. It is a device designed to deliver electrical stimulation to muscles for therapeutic purposes.
The ARP RX100 was cleared through the FDA 510(k) process under k-number K093259, with a traditional clearance pathway and a decision date of December 17, 2009. It is manufactured by Arp Manufacturing, Inc. and is supplied as a single device unit for use in physical medicine settings.
Frequently asked questions
What is the ARP RX100 used for?
The ARP RX100 is designed to deliver electrical stimulation to muscles for therapeutic purposes, as defined under 21 CFR 890.5850 for powered muscle stimulators, and is intended for use in physical medicine settings.
How is the ARP RX100 supplied and is it reusable?
The ARP RX100 is supplied as a single device unit, indicating it is intended for use as one complete system per patient or session, though the data does not specify whether components are single-use or reusable; it is not described as a disposable or multi-patient device.
What regulatory pathway was used for the ARP RX100?
The ARP RX100 received FDA clearance through the traditional 510(k) pathway under k-number K093259, with a decision date of December 17, 2009, and was found substantially equivalent to a predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Operations Manual - arpmanufacturing.com, ARP RX100 (K093259) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093259 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Arp Manufacturing, Inc.
Sources (1)
- FDA 510(k) K093259 24 fields · synced Sep 25, 2026