Product code ILP
- Device name
- System, Communication, Non-Powered
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.3700
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K844890 | TELL ME TAGS - NONPOWERED COMMUNICATION SYS | Mina Manufacturers, Inc. | 1985-03-08 |
| K840112 | SPEECH TEACHER | Joseph A. Resnick | 1984-03-22 |
| K831546 | ADAPTIVE PENS & LAP DESK | Fred Sammons, Inc. | 1983-06-08 |
| K823612 | ADJ. WOODEN BOARD FOR WRITING | Fred Sammons, Inc. | 1982-12-30 |
| K823625 | MOUTH STICK KIT | Fred Sammons, Inc. | 1982-12-30 |
| K823624 | HOLDER FOR MOUTH STICK | Fred Sammons, Inc. | 1982-12-30 |
| K823608 | PICTURES & WORD IDENTIFICATION CVA PAT | Fred Sammons, Inc. | 1982-12-30 |
| K823609 | KIT OF WORDS & LTRS TO RE-LEARN-BK4014 | Fred Sammons, Inc. | 1982-12-22 |
| K823610 | BK-4015 ECONOMY COMMUNICATION SHEET | Fred Sammons, Inc. | 1982-12-22 |
| K823613 | PLASTIC STOP TO HOLD TELEPHONE BUTTON | Fred Sammons, Inc. | 1982-12-22 |
| K823614 | FLEXIBLE HOLDER TO HOLD PHONE RECEIVER | Fred Sammons, Inc. | 1982-12-22 |
| K823615 | TELEPHONE ADAPTOR-PERSONS CANT ANSWER | Fred Sammons, Inc. | 1982-12-22 |
| K823616 | PLASTIC SLIP-ON PEN/PENCIL HOLDER | Fred Sammons, Inc. | 1982-12-22 |
| K823617 | PLASTIC SLIP-ON POINTS W/RUBBER TIP FOR | Fred Sammons, Inc. | 1982-12-22 |
| K821644 | VACUUM WAND AND UNI-READER | Fred Sammons, Inc. | 1982-06-11 |
| K811483 | STIM STAND | Fred Sammons, Inc. | 1981-06-16 |
| K811487 | BOOK HOLDER | Fred Sammons, Inc. | 1981-06-12 |
| K810452 | NON-POWERED COMMUNICATION SYSTEMS | Fred Sammons, Inc. | 1981-03-04 |
| K781204 | BOOK HOLDER | Fred Sammons, Inc. | 1978-07-31 |
| K770032 | PAGE TURNER | Possum, Inc. | 1977-01-12 |
| K761117 | KEYBOARD SHEILDS | Fred Sammons, Inc. | 1976-12-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06974020961372 | Brookstone | Guangdong Newdermo Biotech Co.,Ltd. | 2026-05-28 |
| 18712856075024 | Silk'n | Silkn Beauty Ltd. | 2026-05-07 |
| 06974020961280 | Brookstone | Guangdong Newdermo Biotech Co.,Ltd. | 2026-01-13 |
| 06974020961273 | Brookstone | Guangdong Newdermo Biotech Co.,Ltd. | 2026-01-04 |
| 17290019840043 | Silk'n | Silkn Beauty Ltd. | 2023-11-26 |
| 17290019840050 | Silk'n | Silkn Beauty Ltd. | 2023-11-26 |
| 06974020961006 | WONDER FAMILY | Guangdong Newdermo Biotech Co.,Ltd. | 2023-10-16 |
| 06974020961013 | WONDER FAMILY | Guangdong Newdermo Biotech Co.,Ltd. | 2023-10-16 |
| 06974020960917 | Newdermo | Guangdong Newdermo Biotech Co.,Ltd. | 2023-08-25 |
| G395EZCALL1 | E-Z CALL | Med Labs Inc | 2023-07-12 |
| 06974020960979 | kingdo | Guangdong Newdermo Biotech Co.,Ltd. | 2023-06-01 |
| 06974020960962 | kingdo | Guangdong Newdermo Biotech Co.,Ltd. | 2023-05-30 |
| 06974020960986 | VOGUENOW | Guangdong Newdermo Biotech Co.,Ltd. | 2023-05-30 |
| 06974020960993 | AURA | Guangdong Newdermo Biotech Co.,Ltd. | 2023-05-30 |
| 06974020960948 | VOGUENOW | Guangdong Newdermo Biotech Co.,Ltd. | 2023-05-23 |