ILP · System, Communication, Non-Powered
Physical Medicine · 21 CFR 890.3700 · Class 1
Overview
| Product Code | ILP |
|---|---|
| Device Name | System, Communication, Non-Powered |
| Regulation | 21 CFR 890.3700 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
A nonpowered communication system is a mechanical device intended for medical purposes that is used to assist a patient in communicating when physical impairment prevents writing, telephone use, reading, or talking. Examples of nonpowered communications systems include an alphabet board and a page turner.
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 § 890.9. The device is also 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 (20 of 21)
Showing 20 most recent of 21 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K844890 | TELL ME TAGS - NONPOWERED COMMUNICATION SYS | Mina Manufacturers, Inc. | Mar 8, 1985 | SESE |
| K840112 | SPEECH TEACHER | Joseph A. Resnick | Mar 22, 1984 | SESE |
| K831546 | ADAPTIVE PENS & LAP DESK | Fred Sammons, Inc. | Jun 8, 1983 | SESE |
| K823625 | MOUTH STICK KIT | Fred Sammons, Inc. | Dec 30, 1982 | SESE |
| K823624 | HOLDER FOR MOUTH STICK | Fred Sammons, Inc. | Dec 30, 1982 | SESE |
| K823612 | ADJ. WOODEN BOARD FOR WRITING | Fred Sammons, Inc. | Dec 30, 1982 | SESE |
| K823608 | PICTURES & WORD IDENTIFICATION CVA PAT | Fred Sammons, Inc. | Dec 30, 1982 | SESE |
| K823617 | PLASTIC SLIP-ON POINTS W/RUBBER TIP FOR | Fred Sammons, Inc. | Dec 22, 1982 | SESE |
| K823616 | PLASTIC SLIP-ON PEN/PENCIL HOLDER | Fred Sammons, Inc. | Dec 22, 1982 | SESE |
| K823615 | TELEPHONE ADAPTOR-PERSONS CANT ANSWER | Fred Sammons, Inc. | Dec 22, 1982 | SESE |
| K823614 | FLEXIBLE HOLDER TO HOLD PHONE RECEIVER | Fred Sammons, Inc. | Dec 22, 1982 | SESE |
| K823613 | PLASTIC STOP TO HOLD TELEPHONE BUTTON | Fred Sammons, Inc. | Dec 22, 1982 | SESE |
| K823610 | BK-4015 ECONOMY COMMUNICATION SHEET | Fred Sammons, Inc. | Dec 22, 1982 | SESE |
| K823609 | KIT OF WORDS & LTRS TO RE-LEARN-BK4014 | Fred Sammons, Inc. | Dec 22, 1982 | SESE |
| K821644 | VACUUM WAND AND UNI-READER | Fred Sammons, Inc. | Jun 11, 1982 | SESE |
| K811483 | STIM STAND | Fred Sammons, Inc. | Jun 16, 1981 | SESE |
| K811487 | BOOK HOLDER | Fred Sammons, Inc. | Jun 12, 1981 | SESE |
| K810452 | NON-POWERED COMMUNICATION SYSTEMS | Fred Sammons, Inc. | Mar 4, 1981 | SESE |
| K781204 | BOOK HOLDER | Fred Sammons, Inc. | Jul 31, 1978 | SESE |
| K770032 | PAGE TURNER | Possum, Inc. | Jan 12, 1977 | SESE |
Top Applicants
- Fred Sammons, Inc. — 18 clearances
- Joseph A. Resnick — 1 clearance
- Mina Manufacturers, Inc. — 1 clearance
- Possum, Inc. — 1 clearance
