Scale, Stand-On, Patient
A stand-on patient scale is a platform weighing device used in clinical settings to measure a patient's body weight while standing, supporting monitoring and treatment decisions. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FRI, regulated under 21 CFR 880.2700, within the General Hospital medical specialty. This device is exempt from GMP requirements.
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Basic Information
- Product Code
- FRI
- Device Class
- FDA class 1
- Regulation Number
- 880.2700
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K790130 | SCALE, DIGITAL CHAIR | Feb 01, 1979 | Substantially Equivalent | Acme Medical Scale Co. |
| K770848 | DAILY-WEIGHT | Jun 08, 1977 | Substantially Equivalent | Sr Instruments, Inc. |
| K770847 | PORTA-SCALE | Jun 08, 1977 | Substantially Equivalent | Sr Instruments, Inc. |
FEI Numbers
This FDA classification entry is associated with 91 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 91 registration numbers. Click on an entry to view related FDA registrations.