Identifiers
- 510(k) Number
- K190456 FDA 510(k)
- FDA Product Code
- NGX 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 BTL 799-2L is a Stimulator, Muscle, Powered, For Muscle Conditioning, classified under product code NGX and intended for use in physical medicine applications. It is a powered muscle stimulator designed to deliver electrical stimulation for muscle conditioning purposes.
The device received FDA 510(k) clearance under K190456 on July 5, 2019, following a traditional review process. It is manufactured by BTL Industries, Inc. in Marlborough, Massachusetts, and is classified as a Class II device subject to special controls. No information regarding sterility, single-use or reusable status, MRI safety, sizes, storage conditions, or specific clinical indications is provided in the data.
Frequently asked questions
What is the BTL 799-2L used for?
The BTL 799-2L is intended for muscle conditioning in physical medicine applications, delivering electrical stimulation to support muscle conditioning purposes as a powered muscle stimulator.
How was the BTL 799-2L cleared for market?
The device received FDA 510(k) clearance under K190456 on July 5, 2019, following a traditional review process, and was found substantially equivalent to a predicate device.
Who manufactures the BTL 799-2L and where is it made?
The BTL 799-2L is manufactured by BTL Industries, Inc. at their facility located at 362 Elm St., Marlborough, Massachusetts, 01752, United States.
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: K190456 FDA 510 (k) - BTL 799-2L | BTL Industries, Inc., BTL 799-2L 510 (k) K190456 - FDA.report, BTL 799-2L — FDA 510 (k) K190456 | MedTracker - aiqixie.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190456 | Class II | Active |
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Manufacturer
- Manufacturer
- BTL Industries, Inc.
Sources (1)
- FDA 510(k) K190456 24 fields · synced Sep 26, 2026