Cleared Traditional

K232937 - BTL-899M

K232937 is an FDA 510(k) clearance for BTL-899M, manufactured by BTL Industries, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K232937 · BTL Industries, Inc. · Physical Medicine device
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Dec 2023
Decision
97d
Days
Class 2
Risk

K232937 is an FDA 510(k) clearance for the BTL-899M. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by BTL Industries, Inc. (Marlborough, US). The FDA issued a Cleared decision on December 26, 2023 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all BTL Industries, Inc. devices

FDA 510(k) Submission Details - K232937

510(k) Number K232937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2023
Decision Date December 26, 2023
Days to Decision 97 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 115d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 257
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K232937.
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