FRI · Scale, Stand-On, Patient
General Hospital · 21 CFR 880.2700 · Class 1
Overview
| Product Code | FRI |
|---|---|
| Device Name | Scale, Stand-On, Patient |
| Regulation | 21 CFR 880.2700 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
Identification
A stand-on patient scale is a device intended for medical purposes that is used to weigh a patient who is able to stand on the scale platform.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K790130 | SCALE, DIGITAL CHAIR | Acme Medical Scale Co. | Feb 1, 1979 | SESE |
| K770848 | DAILY-WEIGHT | Sr Instruments, Inc. | Jun 8, 1977 | SESE |
| K770847 | PORTA-SCALE | Sr Instruments, Inc. | Jun 8, 1977 | SESE |
Top Applicants
- Sr Instruments, Inc. — 2 clearances
- Acme Medical Scale Co. — 1 clearance
