The following data is part of a premarket notification filed by Bioness, Inc. with the FDA for H200 Wireless Hand Rehabilitation System With Optional Intelli-connect Earpiece Triggering Device.
| Device ID | K123636 |
| 510k Number | K123636 |
| Device Name: | H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | BIONESS, INC. 25103 RYE CANYON LOOP Valencia, CA 91355 |
| Contact | Kim Tompkins |
| Correspondent | Kim Tompkins BIONESS, INC. 25103 RYE CANYON LOOP Valencia, CA 91355 |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-23 |
| Decision Date | 2013-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110482084 | K123636 | 000 |
| 00815962020535 | K123636 | 000 |
| 00815962020542 | K123636 | 000 |
| 00815962020559 | K123636 | 000 |
| 00815962020566 | K123636 | 000 |
| 00815962020573 | K123636 | 000 |
| 00815962020580 | K123636 | 000 |
| 00815962020597 | K123636 | 000 |
| 00815962020603 | K123636 | 000 |
| 00815962020511 | K123636 | 000 |
| 07290110482008 | K123636 | 000 |
| 07290110482015 | K123636 | 000 |
| 07290110482022 | K123636 | 000 |
| 07290110482039 | K123636 | 000 |
| 07290110482046 | K123636 | 000 |
| 07290110482053 | K123636 | 000 |
| 07290110482060 | K123636 | 000 |
| 07290110482077 | K123636 | 000 |
| 00815962020528 | K123636 | 000 |