Primary Device ID | 00858985006155 |
NIH Device Record Key | ff377b99-9cc7-44fc-9cf9-80f11383f014 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Adjustor |
Version Model Number | VA3 |
Catalog Number | VA3 |
Company DUNS | 004053174 |
Company Name | ERCHONIA CORPORATION, LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00858985006155 [Primary] |
ISA | Massager, Therapeutic, Electric |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-06-29 |
Device Publish Date | 2020-06-19 |
00858985006261 - Erchonia Zerona Z-Bed | 2022-11-08 AESTHETIC - Floor Model Low Level Laser -- 12 diodes 640nm 17mW - OTC (Non-prescriptive) - IFU Reduction Circumference |
00858985006278 - Erchonia GVL | 2022-11-08 MEDICAL - Handheld Low Level Laser - 2 diodes 520nm & 405 nm 7.5 mW - includes induction charger - IFU Reduction Pain, and treat |
00858985006193 - FX405 | 2020-08-18 MEDICAL - Floor Model Low Level Laser - 3 diodes 17.5mW 635nm - 1 diode 23mW 405nm - IFU Pain Reduction, Acne Reduction |
00858985006155 - Adjustor | 2020-06-29THERAPEUTIC – Handheld Variable Adjuster – IFU adjunctive use for treatment of symptoms associate with pain |
00858985006155 - Adjustor | 2020-06-29 THERAPEUTIC – Handheld Variable Adjuster – IFU adjunctive use for treatment of symptoms associate with pain |
00858985006162 - Percussor | 2020-06-29 THERAPEUTIC – Handheld Galvanic Massager – IFU temporary reduction of the appearance of cellulite |
00858985006186 - FX635 | 2020-06-29 MEDICAL - Floor Model Low Level Laser - 3 diodes 17.5mW 635nm - IFU Pain Reduction |
00858985006018 - Emerald | 2020-01-16 AESTHETIC - Floor Model Low Level Laser -- 10 diodes 532nm 17mW - IFU Reduction BMI +30 or greater |
00858985006049 - FX635 | 2019-09-09 MEDICAL - Floor Model Low Level Laser - 3 diodes 17.5mW 635nm - IFU Reduction of Musculoskeletal Pain |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ADJUSTOR 73321301 1275634 Dead/Cancelled |
MGIC INVESTMENT CORPORATION 1981-07-29 |