Product Code: KZM FDA class 2 21 CFR 890.1375

Device, Muscle Monitoring

Physical Medicine

The Muscle Monitoring Device is a diagnostic instrument used in physical medicine and rehabilitation settings to assess muscle activity, tone, or contractile function, providing clinicians with objective data to guide treatment planning and monitor patient progress. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KZM, regulated under 21 CFR 890.1375, in the Physical Medicine medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: KZM
Device Class: FDA class 2
Regulation Number: 890.1375
Medical Specialty: Physical Medicine
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 19 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K161716	TEETHAN 2.0	Dec 21, 2016	Substantially Equivalent	Bts S.P.A.
K130158	M-SCAN	Jul 25, 2013	Substantially Equivalent	Bio-Research Associates, Inc.
K113677	GRINDCARE MEASURE	Apr 05, 2012	Substantially Equivalent	Medotech A/S
K082927	BIOEMG III	Feb 06, 2009	Substantially Equivalent	Bio-Research Associates, Inc.
K043373	DOLOTENS DENTAL TM 1	Sep 02, 2005	Substantially Equivalent	Neuromuscular Technologies, Inc.
K030869	BITESTRIP	May 14, 2004	Substantially Equivalent	S.L.P. , Ltd.
K003176	BIOEMG II AND BIOJVA	Jan 04, 2001	Substantially Equivalent	Bio-Research Associates, Inc.
K003287	MODEL K7 EVALUATION DEVICE	Nov 06, 2000	Substantially Equivalent	Myotronics-Noromed, Inc.
K992694	MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I	Sep 10, 1999	Substantially Equivalent	Myotronics-Noromed, Inc.
K981563	BIOPAK MEASUREMENT SYSTEM	Sep 15, 1998	Substantially Equivalent	Bio-Research Associates, Inc.
K944134	K6-1 DIAGNOSTIC SYSTEM VERSION 3.1	Dec 09, 1994	Substantially Equivalent	Myo-Tronics, Inc.
K922456	K6-I DIAGNOSTIC SYSTEM	Jun 09, 1994	Substantially Equivalent for Some Indications	Myo-Tronics, Inc.
K921919	MS-100 MYO-SCANNER OR MS-100 EMG SCANNER	Jan 07, 1993	Substantially Equivalent	Myo-Tronics, Inc.
K873947	BIO-EMG MODEL 800	Apr 27, 1988	Substantially Equivalent	Bio-Research Associates, Inc.
K862121	E.W.L. P-TENS/H-WAVE	Jun 17, 1987	Substantially Equivalent	Electronic Waveform Laboratory, Inc.
K862092	COMFORTRON	Oct 15, 1986	Substantially Equivalent	M. D. Supply, Inc.
K850425	DENTAL ANESTHESIA APPARATUS	Oct 09, 1986	Substantially Equivalent for Some Indications	Pain Prevention, Inc.
K830034	MODEL EM-2 BIOELECTRIC PROCESSOR	Feb 09, 1983	Substantially Equivalent	Myo-Tronics Research, Inc.
K810528	MODEL EM-IR	Mar 31, 1981	Substantially Equivalent	Myo-Tronics Research, Inc.