Product Code: ISB
FDA class 2
21 CFR 890.1850
Stimulator, Muscle, Diagnostic
Physical Medicine
A diagnostic muscle stimulator is an electrically powered device used to deliver controlled electrical stimulation to muscles for diagnostic assessment of neuromuscular function, including nerve conduction and muscle response. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is ISB, regulated under 21 CFR 890.1850, within the Physical Medicine medical specialty. This device is eligible for third party 510(k) review.
510(k)s
5
FEI Numbers
0
Registration Numbers
0
Unique Applicants
5
Years Active
6
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Basic Information
- Product Code
- ISB
- Device Class
- FDA class 2
- Regulation Number
- 890.1850
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K842805 | IMPULS 3, IT SELECTOR | Aug 01, 1984 | Substantially Equivalent | Robert Bosch Corp. |
| K842262 | PIRD-Y | Jun 28, 1984 | Substantially Equivalent | Pirdy, Inc. |
| K790949 | GALVANIC UNIT | Aug 16, 1979 | Substantially Equivalent | Rami International Corp. |
| K780632 | MAXICEPTOR | Aug 14, 1978 | Substantially Equivalent | Med General |
| K780730 | FIGURETRIM | May 09, 1978 | Substantially Equivalent | Jay-Mar INternational Enterprises, IN |