Guangzhou Xinbo Electronic Co., Ltd.
Manufacturer and brand owner in Guangzhou, Guangdong, China. 18 device types, 15 products catalogued, 12 clearances.
Guangzhou Xinbo Electronic Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Orthosis, Lumbar, Orthosis, Cervical and 16 other device types. 15 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2018.
18device types registered with the FDA
15products catalogued under its own name
12510(k) clearances
Registration
| Registered name | GUANGZHOU XINBO ELECTRONIC CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010097863 |
| FEI number | 3010097863 |
| DUNS | 530683813 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer |
Chinese Registration
| Chinese legal name | 广州市新博电子科技有限公司 |
|---|---|
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Guangzhou |
|---|---|
| Province | Guangdong |
| Address | 23 Building, Phase-II Huachuang Industry Park, Panyu |
| Postal code | 511450 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Apparatus, Traction, Non-Powered | Class 1 | Decompression Belt, DR-HO’s Decompression Belt, HoPhysio Belt | 2018 | 44 |
| Component, Traction, Non-Invasive | Class 1 | Neck Comforter, DR-HO’s Neck Comforter | 2018 | 18 |
| Cushion, Wheelchair | Class 1 | Air Wave Cushion | 2018 | 53 |
| Electrode, Cutaneous | Class 2 | Dr-Ho’s Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III), Conductive Silicone Rubber Electrode, Conductive Carbon Film Electrode, DR-HO’s Foot Pad Electrode, Thigh Muscle Support with Electrodes, Leg Circulation Promoter Blocks with Electrode, Leg Circulation Promoter Cushion with Electrode, and 8 more | 2018 | 47 |
| Massager, Therapeutic, Electric | Class 1 | MotionCiser, MotionCiser Exercise Bands | 2021 | 437 |
| Media, Electroconductive | Class 2 | Electro-Therapy Conductive Gel | 2021 | 8 |
| Orthosis, Cervical | Class 1 | DR-HO’S Adjustable Pillow | 2023 | 114 |
| Orthosis, Corrective Shoe | Class 1 | DR-HO’s Air Orthotics, Diabetic Insoles | 2018 | 51 |
| Orthosis, Limb Brace | Class 1 | Triple Action Back Belt with Dual Support Bands and Adjustable Air Compression,Knee Support with Air Compression, DR-HO’s Knee Compression Support, DR-HO’s Ankle Compression Support, DR-HO’s Foot and Ankle Compression support, DR-HO’s Shoulder Support, DR-HO’s Wrist Support, DR-HO’s Elbow Compression Support,, DR-HO’s Calf Compression Support | 2019 | 144 |
| Orthosis, Lumbar | Class 1 | DR-HO’s Perfect Back Rest, DR-HO’s Back Support Belt | 2018 | 110 |
| Orthosis, Moldable, Supportive, Skin Protective | Class 1 | DR-HO’S Elbow Compression Support(NN-EL-Blue), DR-HO’S Knee Compression Support(NN-KN-Blue), DR-HO’S Calf Compression Support(NN-CA-Blue), DR-HO’S Ankle Compression Support(NN-AN-Blue), DR-HO’S Back Support Belt(NN-LB-Black), DR-HO’S Wrist & Hand Compression Support(NN-WR-Blue) and 1 more | 2021 | 10 |
| Pack, Hot Or Cold, Disposable | Class 1 | Magic Heat Pad, DR-HO’s Heat Therapy Belt | 2018 | 176 |
| Pad, Heating, Powered | Class 2 | Back Pain Relief System Pro | 2021 | 144 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | Class 2 | Pain Therapy DH-PTS-I, DH-PTS-II, DH-PTS-IIA, DH-PTS-IIB, DH-CP-I, Back Pain Relief System Pro, Pain Therapy System Models: P.T.S-III, Pain Therapy Device (Model: P.T.S.-Vi, P.T.S.-Vii), Pain Therapy Device (Model: P.TS.-X), Equate Pain Therapy and 4 more | 2018 | 22 |
| Stimulator, Muscle, Powered | Class 2 | Pain Therapy DH-PTS-I, DH-PTS-II, DH-PTS-IIA, DH-PTS-IIB, DH-CP-I, Pain Therapy System Models: P.T.S-III, Pain Therapy Device (Model: P.T.S.-Vi, P.T.S.-Vii), Pain Therapy Device (Model: P.TS.-X) | 2021 | 33 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | Class 2 | Pain Therapy DH-PTS-I, DH-PTS-II, DH-PTS-IIA, DH-PTS-IIB, DH-CP-I, Back Pain Relief System Pro, Pain Therapy System Models: P.T.S-III, Pain Therapy Device (Model: P.T.S.-Vi, P.T.S.-Vii), Pain Therapy Device (Model: P.TS.-X), Equate Pain Therapy and 4 more | 2018 | 66 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | Class 2 | Pain Therapy DH-PTS-I, DH-PTS-II, DH-PTS-IIA, DH-PTS-IIB, DH-CP-I, Pain Therapy System Models: P.T.S-III, Pain Therapy Device (Model: P.T.S.-Vi, P.T.S.-Vii), Pain Therapy Device (Model: P.TS.-X) | 2021 | 32 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | Class 2 | Pain Therapy DH-PTS-I, DH-PTS-II, DH-PTS-IIA, DH-PTS-IIB, DH-CP-I, Back Pain Relief System Pro, Pain Therapy System Models: P.T.S-III, Pain Therapy Device (Model: P.T.S.-Vi, P.T.S.-Vii), Pain Therapy Device (Model: P.TS.-X), Equate Pain Therapy and 4 more | 2018 | 57 |
Own-Brand Listings
Clearances
12 clearances name Guangzhou Xinbo Electronic Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K230711 | 2024-05-16 | NGX | Traditional | This company |
| K231789 | 2024-03-11 | NGX | Traditional | This company |
| K231167 | 2023-08-09 | GXY | Traditional | This company |
| K231164 | 2023-08-09 | GXY | Traditional | This company |
| K202671 | 2021-11-12 | NUH | Traditional | This company |
| K212948 | 2021-11-01 | NGX | Traditional | This company |
| K202636 | 2021-08-16 | GXY | Traditional | This company |
| K202638 | 2021-07-15 | NGX | Traditional | This company |
| K200402 | 2020-11-25 | GYB | Traditional | This company |
| K190118 | 2020-05-13 | GXY | Traditional | This company |
| K172887 | 2018-04-19 | GXY | Traditional | This company |
| K163611 | 2017-09-19 | NUH | Traditional | This company |
| K151693 | 2015-10-09 | GXY | Traditional | Drtv Asia Ltd |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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