510(k) K760503
- Device
- STIMULATOR, ELECTRICAL MUSCLE (#MD-8)
- Applicant
- R. A. FISCHER CO. CORP.
- 510(k) number
- K760503
- Product code
- IPF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-09-27
- Date received
- 1976-08-23
- Regulation
- 890.5850
- Classification name
- Stimulator, Muscle, Powered
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2954348
- 3017263740
- 3007731000
- 1054713
- 3027241812
- 3005713796
- 3009494725
- 3011905669
- 3017936974
- 1721293
- 3045753434
- 3001676837
- 3004509773
- 3007743972
- 3013602304
- 3043011436
- 3025367760
- 3010078417
- 3011466827
- 3013375723
- 3006153348
- 3030956509
- 3019892999
- 3001431138
- 9710567
- 3012651177
- 3008048783
- 3005868392
- 3014774380
- 9613462
- 3012316249
- 3043657394
- 3016670292
- 8022189
- 3037609256
- 3013445676
- 3007543044
- 3010097863
- 2013558
- 3005170249
- 3008008477
- 3008273892
- 3014315574
- 1061158
- 9710616
- 3019055598
- 3013508647
- 8040537
- 3044563261
- 3011191255
- 1911273
- 3009437400
- 3004438577
- 3004264602
- 3016508547
- 3009538657
- 3004183512
- 3049809930
- 3008525454
- 3003740945
- 2011115
- 3006551156
- 3036471706
- 9615033
- 3027669735
- 3004146401
- 3010385841
- 3033847811
- 3008770252
- 3004753827
- 3011564440
- 3015588280
- 3016087653
- 9616086
- 1930027
- 3010405397
- 9710580
- 3016453096
- 3017450375
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IPF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253542 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | 2026-06-08 |
| K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP) | Mohammadali Nezakati | 2026-06-02 |
| K260142 | StimelMD (SSMD) system | Motion Informatics ltd. | 2026-05-27 |
| K251083 | Compact II | Enraf-Nonius, B.V. | 2025-09-12 |
| K241433 | EVE Synergy (EVE-20M) | Weero Co., Ltd. | 2025-06-04 |
| K241488 | TrainFES Advance | Trainfes | 2025-02-05 |
| K240348 | Quantum Mitohormesis (QMT) (M2101) | Quantumtx Pte. , Ltd. | 2024-12-19 |
| K240992 | eMVFit (MVF-10M) | Weero Co., Ltd. | 2024-10-10 |
| K240234 | BTL-899MS | BTL Industries, Inc. | 2024-08-17 |
| K233098 | MYOTouch Muscle Stimulator | Sunmed, LLC | 2024-08-02 |
| K232786 | Stimulation System (PA series, PR series, S series and Q series) | Edan Instruments, Inc. | 2024-05-16 |
| K233926 | accufit | Mettler Electronics Corporation | 2024-03-21 |
| K233485 | M-Wave | Zynex Medical, Inc. | 2024-01-26 |
| K232937 | BTL-899M | BTL Industries, Inc. | 2023-12-26 |
| K230701 | Stim2Go | PAJUNK GmbH Medizintechnologie | 2023-11-24 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases